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1.

Introduction:

The activities involving phlebotomy, a critical task for obtaining diagnostic blood samples, are poorly studied as regards the major sources of errors and the procedures related to laboratory quality control. The aim of this study was to verify the compliance with CLSI documents of clinical laboratories from South America and to assess whether teaching phlebotomists to follow the exact procedure for blood collection by venipuncture from CLSI/NCCLS H03-A6 - Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture might improve the quality of the process.

Materials and methods:

A survey was sent by mail to 3674 laboratories from South America to verify the use of CLSI documents. Thirty skilled phlebotomists were trained with the CLSI H03-A6 document to perform venipuncture procedures for a period of 20 consecutive working days. The overall performances of the phlebotomists were further compared before and after the training program.

Results:

2622 from 2781 laboratories that did answer our survey used CLSI documents to standardize their procedures and process. The phlebotomists’ training for 20 days before our evaluation completely eliminated non-conformity procedures for: i) incorrect friction of the forearm, during the cleaning of the venipuncture site to ease vein location; ii) incorrect sequence of vacuum tubes collection; and iii) inadequate mixing of the blood in primary vacuum tubes containing anticoagulants or clot activators. Unfortunately the CLSI H03-A6 document does not caution against both unsuitable tourniquet application time (i.e., for more than one minute) and inappropriate request to clench the fist repeatedly. These inadequate procedures were observed for all phlebotomists.

Conclusion:

We showed that strict observance of the CLSI H03-A6 document can remarkably improve quality, although the various steps for collecting diagnostic blood specimens are not a gold standard, since they may still permit errors. Tourniquet application time and forearm clench should be verified by all quality laboratory managers in the services. Moreover, the procedure for collecting blood specimens should be revised to eliminate this source of laboratory variability and safeguard the quality.  相似文献   

2.

Introduction

This study aimed to assess confidence level of healthcare professionals in venipuncture and their knowledge on the possible causes of in vitro hemolysis.

Materials and methods

A sample of 94 healthcare professionals (nurses and laboratory technicians) participated in this survey study. A four-section questionnaire was used as a research instrument comprising general information for research participants, knowledge on possible causes of in vitro hemolysis due to type of material used and venipuncture technique and specimen handling, as well as assessment of healthcare professionals’ confidence level in their own ability to perform first and last venipuncture.

Results

The average score on the knowledge test was higher in nurses’ than in laboratory technicians (8.11 ± 1.7, and 7.4 ± 1.5, respectively). The difference in average scores was statistically significant (P = 0.035) and Cohen’s d in the range of 0.4 indicates that there is a moderate difference on the knowledge test among the health care workers. Only 11/94 of healthcare professionals recognized that blood sample collection from cannula and evacuated tube is method which contributes most to the occurrence of in vitro hemolysis, whereas most risk factors affecting occurrence of in vitro hemolysis during venipuncture were recognized. There were no significant differences in mean score on the knowledge test in relation to the confidence level in venipuncture (P = 0.551).

Conclusion

Confidence level at last venipuncture among both profiles of healthcare staff was very high, but they showed insufficient knowledge about possible factors affecting hemolysis due to materials used in venipuncture compared with factors due to venipuncture technique and handling of blood sample.Key words: hemolysis, patient safety, phlebotomy, medical staff, questionnaire, preanalytical phase  相似文献   

3.

Introduction:

Capillary sampling is increasingly used to obtain blood for laboratory tests in volumes as small as necessary and as non-invasively as possible. Whether capillary blood sampling is also frequent in Croatia, and whether it is performed according to international laboratory standards is unclear.

Materials and methods:

All medical laboratories that participate in the Croatian National External Quality Assessment Program (N = 204) were surveyed on-line to collect information about the laboratory’s parent institution, patient population, types and frequencies of laboratory tests based on capillary blood samples, choice of reference intervals, and policies and procedures specifically related to capillary sampling. Sampling practices were compared with guidelines from the Clinical and Laboratory Standards Institute (CLSI) and the World Health Organization (WHO).

Results:

Of the 204 laboratories surveyed, 174 (85%) responded with complete questionnaires. Among the 174 respondents, 155 (89%) reported that they routinely perform capillary sampling, which is carried out by laboratory staff in 118 laboratories (76%). Nearly half of respondent laboratories (48%) do not have a written protocol including order of draw for multiple sampling. A single puncture site is used to provide capillary blood for up to two samples at 43% of laboratories that occasionally or regularly perform such sampling. Most respondents (88%) never perform arterialisation prior to capillary blood sampling.

Conclusions:

Capillary blood sampling is highly prevalent in Croatia across different types of clinical facilities and patient populations. Capillary sampling procedures are not standardised in the country, and the rate of laboratory compliance with CLSI and WHO guidelines is low.  相似文献   

4.

Introduction:

Preanalytical variables account for most of laboratory errors. There is a wide range of factors that affect the reliability of laboratory report. Most convenient sample type for routine laboratory analysis is serum. BD Vacutainer® Rapid Serum Tube (RST) (Becton, Dickinson and Company, Franklin Lakes, NJ, USA) blood collection tube provides rapid clotting time allowing fast serum separation. Our aim was to evaluate the comparability of routine chemistry parameters in BD Vacutainer® RST blood collection tube in reference with the BD Vacutainer® Serum Separating Tubes II Advance Tube (SST) (Becton, Dickinson and Company, Franklin Lakes, NJ, USA).

Materials and methods:

Blood specimens were collected from 90 participants for evaluation on its results, clotting time and stability study of six routine biochemistry parameters: glucose (Glu), aspartate aminotransferase (AST), alanine aminotransferase (ALT), calcium (Ca), lactate dehidrogenase (LD) and potassium (K) measured with Olympus AU2700 analyzer (Beckman Coulter, Tokyo, Japan). The significance of the differences between samples was assessed by paired t-test or Wilcoxon Matched-Pairs Rank test after checking for normality.

Results:

Clotting process was significantly shorter in the RSTs compared to SSTs (2.49 min vs. 19.47 min, respectively; P < 0.001). There was a statistically significant difference between the RST and SST II tubes for glucose, calcium and LD (P < 0.001). Differences for glucose and LD were also clinically significant. Analyte stability studies showed that all analytes were stable for 24 h at 4 °C.

Conclusions:

Most results (except LD and glucose) from RST are comparable with those from SST. In addition, RST tube provides shorter clotting time.  相似文献   

5.
Phlebotomy is one of the most complex medical procedures in the diagnosis, management and treatment of patients in healthcare. Since laboratory test results are the basis for a large proportion (60–80%) of medical decisions, any error in the phlebotomy process could have serious consequences. In order to minimize the possibility of errors, phlebotomy procedures should be standardised, well-documented and written instructions should be available at every workstation. Croatia is one of the few European countries that have national guidelines for phlebotomy, besides the universally used CLSI (Clinical Laboratory Standards Institute) H3-A6 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; approved Standard-Sixth Edition (CLSI, 2007) and WHO (World Health Organization) guidelines on drawing blood: best practices in phlebotomy (WHO, 2010). However, the growing body of evidence in importance of preanalytical phase management resulted in a need for evidence based revision and expansion of existing recommendations.The Croatian Society for Medical Biochemistry and Laboratory Medicine, Working Group for the Preanalytical Phase issued this recommendation. This document is based on the CLSI guideline H3-A6, with significant differences and additional information.  相似文献   

6.

Background:

In vitro hemolysis can be induced by several biological and technical sources, and may be worsened by forced aspiration of blood in vacuum tubes. This study was aimed to compare the probability of hemolysis by drawing blood with a commercial evacuated blood collection tube, and S-Monovette used either in the “vacuum” or “aspiration” mode.

Materials and methods:

The study population consisted in 20 healthy volunteers. A sample was drawn into 4.0 mL BD Vacutainer serum tube from a vein of one upper arm. Two other samples were drawn with a second venipuncture from a vein of the opposite arm, into 4.0 mL S-Monovette serum tubes, by both vacuum an aspiration modes. After separation, serum potassium, lactate dehydrogenase (LD) and hemolysis index (HI) were tested on Beckman Coulter DxC.

Results:

In no case the HI exceed the limit of significant hemolysis. As compared with BD Vacutainer, no significant differences were observed for potassium and LD using S-Monovette with vacuum method. Significant increased values of both parameters were however found in serum collected into BD Vacutainer and S-Monovette by vacuum mode, compared to serum drawn by S-Monovette in aspiration mode. The mean potassium bias was 2.2% versus BD Vacutainer and 2.4% versus S-Monovette in vacuum mode, that of LD was 2.7% versus BD Vacutainer and 2.1% versus S-Monovette in vacuum mode. None of these variations exceeded the allowable total error.

Conclusions:

Although no significant macro-hemolysis was observed with any collection system, the less chance of producing micro-hemolysis by S-Monovette in aspiration mode suggest that this device may be used when a difficult venipuncture combined with the vacuum may increase the probability of spurious hemolysis.  相似文献   

7.

Background

It is still uncertain whether or not avoidance to let disinfectant alcohol dry at the site of venipuncture is a source of spurious hemolysis when drawing venous blood.

Methods:

In a consecutive series of 52 outpatients referred for routine laboratory testing, venous blood was drawn by direct venipuncture with (odd group) or without (pair group) wiping 70% isopropyl alcohol at the site of venipuncture. A 3.5 mL evacuated tube with clot activator and gel separator was drawn from a vein of the upper limb, serum was immediately separated with standard centrifugation and tested for potassium, lactate dehydrogenase (LD), aspartate aminotransferase (AST) and hemolysis index (HI) on Roche Cobas.

Results:

No specimen was discarded for unsatisfactory venipuncture. No differences for age and gender were observed between groups. As regards the four parameters investigated, no significant differences could be observed between patients in whom blood was drawn with or without letting the alcohol dry. It is also noteworthy that no sample in both groups exceeded the conventional sample rejection threshold of cell-free hemoglobin.

Conclusions:

The results of our prospective, randomized study attest that failure to wipe alcohol at the site of venipuncture should not be considered as a potential source of spurious hemolysis when drawing blood.  相似文献   

8.
Procedures involving phlebotomy are critical for obtaining diagnostic blood specimens and represent a well known and recognized problem, probably among the most important issues in laboratory medicine. The aim of this report is to show spurious hyperkalemia and hypocalcemia due to inadequate phlebotomy procedure. The diagnostic blood specimens were collected from a male outpatient 45 years old, with no clinical complaints. The tubes drawing order were as follows: i) clot activator and gel separator (serum vacuum tube), ii) K3EDTA, iii) a needleless blood gas dedicated-syringe with 80 I.U. lithium heparin, directly connected to the vacuum tube holder system. The laboratory testing results from serum vacuum tube and dedicated syringe were 4.8 and 8.5 mmol/L for potassium, 2.36 and 1.48 mmol/L for total calcium, respectively. Moreover 0.15 mmol/L of free calcium was observed in dedicated syringe. A new blood collection was performed without K3EDTA tube. Different results were found for potassium (4.7 and 4.5 mmol/L) and total calcium (2.37 and 2.38 mmol/L) from serum vacuum tube and dedicated syringe, respectively. Also free calcium showed different concentration (1.21 mmol/L) in this new sample when compared with the first blood specimen. Based on this case we do not encourage the laboratory managers training the phlebotomists to insert the dedicated syringes in needle-holder system at the end of all vacuum tubes. To avoid double vein puncture the dedicated syringe for free calcium determination should be inserted immediately after serum tubes before EDTA vacuum tubes.  相似文献   

9.

Background

Due to the high prevalence of hemolysis in specimens received from the emergency department (ED), several strategies have been proposed to improve sample quality, but none of these seem effective to overcome the problem. In a preliminary study we showed that the use of S-Monovette blood collection system was effective to lower the risk of hemolysis in venous blood samples collected from intravenous catheters. This study was hence aimed to verify whether the replacement of a conventional vacuum system with S-Monovette may be effective to reduce the burden of hemolysis in the daily practice of a large urban ED.

Materials and methods

The study was divided in two observational periods of 4 months each. In the former period, blood was collected from intravenous catheters using BD Vacutainer SST II Plus plastic serum tubes, whereas in the latter period the blood was drawn from intravenous catheters using S-Monovette blood tubes in aspiration mode. Sample hemolysis was automatically assessed in all serum samples by photometrical measurement.

Results

The total number of hemolysed serum specimens was 624/14155 (4.41%) in the first phase of the study, and 342/13319 (2.57%) in the second phase of the study (P < 0.001).

Conclusion

Results of our study confirm that the introduction of the Sarstedt S-Monovette blood tubes has reduced the hemolysis rate in the emergency department compared to the previously used BD Vacutainer® SST II Plus plastic serum tubes.Key words: preanalytical phase, hemolysis, blood specimen collection, catheter, emergency department  相似文献   

10.

Introduction

Presepsin, the circulating soluble form of CD14 subtype (sCD14-ST) is a new emerging early marker for sepsis. Various cutoff levels of presepsin have been proposed, to discriminate between systemic bacterial and nonbacterial infectious diseases. The aim of this work was to define the reference interval for presepsin according to the CLSI C28-A3c approved guideline.

Materials and methods

Reference individuals (N = 200; 120 females) aged 18-75 years (median 39 years), free from inflammatory diseases, were selected for the study. Presepsin concentrations were measured by a commercially available chemiluminescent enzyme immunoassay (PATHFASTTM, Mitsubishi Chemical Europe GmbH, Düsseldorf, Germany). Reference limits were calculated using the non-parametric percentile method.

Results

Overall, the reference limits for the presepsin were 55–184 pg/mL (90% confidence intervals, CI, were 45 to 58 and 161 to 214, respectively). There were no significant differences between males and females and the presepsin concentrations were not even particularly influenced by age. The upper reference limit for the presepsin is much lower than every cut-off limit so far proposed, both for sepsis and also for systemic inflammatory response syndrome.

Conclusion

Specific decision levels are required to define the diagnostic and prognostic roles of presepsin in different settings of inflammatory and infectious diseases. Reference values can help to distinguish and quickly rule out healthy subjects or patients with other pathologies.Key words: CD14 Antigen, presepsin, reference values, male, female, Clinical and Laboratory Standard Institute  相似文献   

11.
A new device called Buzzy® has been recently presented that combines a cooling ice pack and a vibrating motor in order to relieve the venipuncture pain. The aim of this study was to evaluate the impact of Buzzy® use during diagnostic blood specimen collection by venipuncture for routine immunochemistry tests. Blood was collected from 100 volunteers by a single, expert phlebotomist. A vein was located on the left forearm without applying tourniquet, in order to prevent any interference from venous stasis, and blood samples were collected using a 20-G straight needle directly into 5 mL vacuum tubes with clot activator and gel separator. In sequence, external cold and vibration by Buzzy® was applied on the right forearm—5 cm above the chosen puncture site—for 1 min before venipuncture and continued until the end of the same procedure already done in the left forearm. The panel of tests included the following: glucose, total cholesterol, HDL-cholesterol, triglycerides, total protein, albumin, c-reactive protein, urea, creatinine, uric acid, alkaline phosphatase, amylase, AST, ALT, g-glutamyltransferase, lactate dehydrogenase, creatine kinase, total bilirubin, phosphorus, calcium, magnesium, iron, sodium, potassium, chloride, lipase, cortisol, insulin, thyroid-stimulating hormone, total triiodothyronine, free triiodothyronine, total thyroxine, free thyroxine and haemolysis index. Clinically significant differences between samples were found only for: total protein, albumin and transferrin. The Buzzy® can be used during diagnostic blood specimens collection by venipuncture for the majority of the routine immunochemistry tests. We only suggest avoiding this device during blood collection when protein, albumin and transferrin determinations should be performed.  相似文献   

12.

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   

13.

Introduction:

Proper preparation of the individual is a key prerequisite for ensuring the quality of laboratory testing. Our hypothesis was that many outpatients are not sufficiently familiar with the correct way of preparing for the laboratory tests, for which the individual needs to be at fasting. This study aimed to investigate: i) whether patients are aware of how they need to prepare properly for laboratory tests; ii) the way in which users are informed about how to prepare for laboratory testing; and iii) whether users arrive to the laboratory for phlebotomy properly prepared.

Materials and methods:

An anonymous questionnaire was conducted on 150 outpatients older than 18 years, during February 2013. The response rate was 11%. All patients were interviewed by the laboratory staff. Patients were informed about detail of the questionnaire and agreed to participate in the survey.

Results:

Out of the total number subjects, 39% were fully aware of the proper definition of the fasting, whereas even 46% subjects replied that the last meal has to be taken the day before and the exact time that must pass after the last meal to blood sampling is not important. Furthermore, 52% subjects did not receive any information about how they need to prepare themselves properly for blood testing. Only 60% of them came properly prepared for the laboratory blood testing.

Conclusions:

Substantial proportion of patients do not come properly prepared for laboratory testing. We conclude that patients are not well informed about the fasting requirements for laboratory blood testing. Moreover, requesting physician is the preferred source of information from which patients learn how to prepare themselves for phlebotomy.  相似文献   

14.

Introduction:

Preanalytical errors, along the process from the beginning of test requests to the admissions of the specimens to the laboratory, cause the rejection of samples. The aim of this study was to better explain the reasons of rejected samples, regarding to their rates in certain test groups in our laboratory.

Materials and methods:

This preliminary study was designed on the rejected samples in one-year period, based on the rates and types of inappropriateness. Test requests and blood samples of clinical chemistry, immunoassay, hematology, glycated hemoglobin, coagulation and erythrocyte sedimentation rate test units were evaluated. Types of inappropriateness were evaluated as follows: improperly labelled samples, hemolysed, clotted specimen, insufficient volume of specimen and total request errors.

Results:

A total of 5,183,582 test requests from 1,035,743 blood collection tubes were considered. The total rejection rate was 0.65 %. The rejection rate of coagulation group was significantly higher (2.28%) than the other test groups (P < 0.001) including insufficient volume of specimen error rate as 1.38%. Rejection rates of hemolysis, clotted specimen and insufficient volume of sample error were found to be 8%, 24% and 34%, respectively. Total request errors, particularly, for unintelligible requests were 32% of the total for inpatients.

Conclusions:

The errors were especially attributable to unintelligible requests of inappropriate test requests, improperly labelled samples for inpatients and blood drawing errors especially due to insufficient volume of specimens in a coagulation test group. Further studies should be performed after corrective and preventive actions to detect a possible decrease in rejecting samples.  相似文献   

15.

Introduction:

We have previously shown that the concentrations of D-dimer are significantly elevated in saliva compared with plasma. Saliva offers several advantages compared with blood analysis. We hypothesised that human saliva contains plasminogen activator inhibitor-1 (PAI-1) and that the concentrations are not affected by the time of saliva collection. The aim was to adopt and validate an immunoassay to quantify PAI-1 concentrations in saliva and to determine whether saliva collection time has an influence in the measurement.

Materials and methods:

Two saliva samples (morning and afternoon) from the same day were collected from healthy subjects (N = 40) who have had no underlying heart conditions. A customized AlphaLISA® immunoassay (PerkinElmer®, MA, USA) was adopted and used to quantify PAI-1 concentrations. We validated the analytical performance of the customized immunoassay by calculating recovery of known amount of analyte spiked in saliva.

Results:

The recovery (95.03%), intra- (8.59%) and inter-assay (7.52%) variations were within the acceptable ranges. The median salivary PAI-1 concentrations were 394 pg/mL (interquartile ranges (IQR) 243.4–833.1 pg/mL) in the morning and 376 (129.1–615.4) pg/mL in the afternoon and the plasma concentration was 59,000 (24,000–110,000) pg/mL. Salivary PAI-1 did not correlate with plasma (P = 0.812).

Conclusions:

The adopted immunoassay produced acceptable assay sensitivity and specificity. The data demonstrated that saliva contains PAI-1 and that its concentration is not affected by the time of saliva collection. There is no correlation between salivary and plasma PAI-1 concentrations. Further studies are required to demonstrate the utility of salivary PAI-1 in CVD risk factor studies.  相似文献   

16.

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   

17.

Background:

Presently the necessity of fasting time for coagulation tests is not standardized. Our hypothesis is that this can harm patient safety. This study is aimed at evaluating whether a light meal (i.e. breakfast) can jeopardize laboratory coagulation tests.

Materials and methods:

A blood sample was firstly collected from 17 fasting volunteers (12 h). Immediately after blood collection, the volunteers consumed a light meal. Then samples were collected at 1, 2 and 4 h after the meal. Coagulation tests included: activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen (Fbg), antithrombin III (AT), protein C (PC) and protein S (PS). Differences between samples were assessed by Wilcoxon ranked-pairs test. The level of statistical significance was set at P < 0.05. Mean % differences were determined and differences between and baseline and 1, 2 and 4h samples were compared with reference change value (RCV).

Results:

A significantly higher % activity of AT was observed at 1 h and 4 h after meal vs. baseline specimen [113 (104–117) and 111 (107–120) vs. 109 (102–118), respectively; P = 0.029 and P = 0.016]. APTT at 2 h was found significantly lower than baseline samples [32.0 (29.9–34.8) vs. 34.1 (32.2–35.2), respectively; P = 0.041]. The results of both Fbg and PS tests were not influenced by a light meal. Furthermore, no coagulation tests had significant variation after comparison with RCV.

Conclusion:

A light meal does not influence the laboratory coagulation tests we assessed, but we suggest that the laboratory quality managers standardize the fasting time for all blood tests at 12 hours, to completely metabolize the lipids intake.  相似文献   

18.

Background:

A number of preanalytical activities strongly influence sample quality, especially those related to sample collection. Since blood drawing through intravenous catheters is reported as a potential source of erythrocyte injury, we performed a critical review and meta-analysis about the risk of catheter-related hemolysis.

Materials and methods:

We performed a systematic search on PubMed, Web of Science and Scopus to estimate the risk of spurious hemolysis in blood samples collected from intravenous catheters. A meta-analysis with calculation of Odds ratio (OR) and Relative risk (RR) along with 95% Confidence interval (95% CI) was carried out using random effect mode.

Results:

Fifteen articles including 17 studies were finally selected. The total number of patients was 14,796 in 13 studies assessing catheter and evacuated tubes versus straight needle and evacuated tubes, and 1251 in 4 studies assessing catheter and evacuated tubes versus catheter and manual aspiration. A significant risk of hemolysis was found in studies assessing catheter and evacuated tubes versus straight needle and evacuated tubes (random effect OR 3.4; 95% CI = 2.9–3.9 and random effect RR 1.07; 95% CI = 1.06–1.08), as well as in studies assessing catheter and evacuated tubes versus catheter and manual aspiration of blood (OR 3.7; 95% CI = 2.7–5.1 and RR 1.32; 95% CI = 1.24–1.40).

Conclusions:

Sample collection through intravenous catheters is associated with significant higher risk of spurious hemolysis as compared with standard blood drawn by straight needle, and this risk is further amplified when intravenous catheter are associated with primary evacuated blood tubes as compared with manual aspiration.  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

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   

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