共查询到20条相似文献，搜索用时 31 毫秒
1.
Gabriel Lima-Oliveira Giuseppe Lippi Gian Luca Salvagno Martina Montagnana Geraldo Picheth Gian Cesare Guidi 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2012,22(3):342-351
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.
Gabriel Lima-Oliveira Giuseppe Lippi Gian Luca Salvagno Martina Montagnana Geraldo Picheth Gian Cesare Guidi 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2013,23(3):308-315
Introduction:
The phlebotomists’ procedures are a still source of laboratory variability. The aim of this study was to verify the efficacy of minor modification in procedure for collection of diagnostic blood specimens by venipuncture from CLSI H03-A6 document is able to reduce the tourniquet application time.Materials and methods:
Thirty phlebotomists were invited to participate. Each phlebotomist was trained individually to perform the new venipuncture procedure that shortens the time of tourniquet release and removal. The phlebotomy training program was delivered over 8h. After training, all phlebotomists were monitored for 20 working days, to guarantee the adoption of the correct new procedures for collection of diagnostic blood specimens. After this time frame the phlebotomists were evaluated to verify whether the new procedure for blood collection derived from CLSI H03-A6 document was effective to improve the quality process by decrease in tourniquet application time. We compared the tourniquet application time and qualitative difference of phlebotomy procedures between laboratories before and after phlebotomy training.Results:
The overall mean ± SD tourniquet application time before and after this intervention were 118 ± 1 s and 30 ± 1 s respectively. Minor modifications in procedure for blood collection were able to reduce significantly the tourniquet application time (−88 s, P < 0.001).Conclusions:
The minor modifications in procedure for collection of diagnostic blood specimens by venipuncture from CLSI H03-A6 document were able to reduce the tourniquet application time. Now the proposed new procedure for collection of diagnostic blood specimens by venipuncture could be considered usefulness and should be put into practice by all quality laboratory managers and/or phlebotomy coordinators to avoid preanalytical errors regard venous stasis and guarantee patient safety. 相似文献3.
Jasna Lenicek Krleza 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2014,24(3):350-358
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.
Cristiano Ialongo Sergio Bernardini 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2016,26(1):17-33
The evidence-based paradigm has changed and evolved medical practice. Phlebotomy, which dates back to the age of ancient Greece, has gained experience through the evolution of medicine becoming a fundamental diagnostic tool. Nowadays it connects the patient with the clinical laboratory dimension building up a bridge. However, more often there is a gap between laboratory and phlebotomist that causes misunderstandings and burdens on patient safety. Therefore, the scope of this review is delivering a view of modern phlebotomy to “bridge” patient and laboratory. In this regard the paper describes devices, tools and procedures in the light of the most recent scientific findings, also discussing their impact on both quality of blood testing and patient safety. It also addresses the issues concerning medical aspect of venipuncture, like the practical approach to the superficial veins anatomy, as well as the management of the patient’s compliance with the blood draw. Thereby, the clinical, technical and practical issues are treated with the same relevance throughout the entire paper.Key words: phlebotomy, venipuncture, laboratory testing, preanalytical phase, preanalytical variability, patient safety, evidence based medicine 相似文献
5.
Gabriella De Carli Dominique Abiteboul Vincenzo Puro 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2014,24(1):45-56
Healthcare workers are at risk of sharps injuries and subsequent infection from more than 40 bloodborne pathogens or species. Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) together account for the vast majority of cases. The Directive 2010/32/EU “Prevention from sharp injuries in the hospital and healthcare sector”, issued to protect workers from these risks, requires an integrated approach to prevention including awareness-raising, education, training, elimination of unnecessary needles, safe procedures for sharps use and disposal, banning of recapping, vaccination, use of personal protective equipment, provision of safety-engineered devices, and appropriate surveillance, monitoring, response and follow-up.As laboratories represent a high-risk setting both in the preanalytical and analytical phase, we reviewed accidents and prevention in this setting in the light of the new legislation.Phlebotomy is the procedure carrying the highest risk of exposure and infection, involved in 30–50% of HIV and HCV cases detected in nationwide systems following accidental blood exposures implemented since the 1990s in Italy and France. In laboratories, problems in the management of sharps containers, recapping, needle disassembly by hand and blood transfer from syringes into tubes were observed and accounted for two-thirds of injuries. These accidents could be reduced through education and monitoring of behaviours, and introduction of medical devices incorporating safety-engineered protection mechanisms with appropriate training. Laboratory staff should be immunized against HBV, and know policies and procedures for the post-exposure management and prophylaxis. The management commitment to safety is crucial to ensure the necessary support to these changes. 相似文献
6.
Yesim Ozarda 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2016,26(1):5-11
Reliable and accurate reference intervals (RIs) for laboratory analyses are an integral part of the process of correct interpretation of clinical laboratory test results. RIs given in laboratory reports have an important role in aiding the clinician in interpreting test results in reference to values for healthy populations. Since the 1980s, the International Federation of Clinical Chemistry (IFCC) has been proactive in establishing recommendations to clarify the true significance of the term ‘RIs, to select the appropriate reference population and statistically analyse the data. The C28-A3 guideline published by the Clinical and Laboratory Standards Institute (CLSI) and IFCC is still the most widely-used source of reference in this area. In recent years, protocols additional to the Guideline have been published by the IFCC, Committee on Reference Intervals and Decision Limits (C-RIDL), including all details of multicenter studies on RIs to meet the requirements in this area. Multicentric RIs studies are the most important development in the area of RIs. Recently, the C-RIDL has performed many multicentric studies to obtain common RIs. Confusion of RIs and clinical decision limits (CDLs) remains an issue and pediatric and geriatric age groups are a significant problem. For future studies of RIs, the genetic effect would seem to be the most challenging area.
The aim of the review is to present the current theory and practice of RIs, with special emphasis given to multicenter RIs studies, RIs studies for pediatric and geriatric age groups, clinical decision limits and partitioning by genetic effects on RIs.Key words: multicenter study, common reference intervals, reference values, clinical decision limits, genetic information 相似文献
The aim of the review is to present the current theory and practice of RIs, with special emphasis given to multicenter RIs studies, RIs studies for pediatric and geriatric age groups, clinical decision limits and partitioning by genetic effects on RIs.Key words: multicenter study, common reference intervals, reference values, clinical decision limits, genetic information 相似文献
7.
Vera Luki&#x; Svetlana Ignjatovi&#x; 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2022,32(1)
IntroductionMoving average (MA) is one possible way to use patient results for analytical quality control in medical laboratories. The aims of this study were to: (1) implement previously optimized MA procedures for 10 clinical chemistry analytes into the laboratory information system (LIS); (2) monitor their performance as a real-time quality control tool, and (3) define an algorithm for MA alarm management in a small-volume laboratory to suit the specific laboratory.Materials and methodsMoving average alarms were monitored and analysed over a period of 6 months on all patient results (total of 73,059) obtained for 10 clinical chemistry parameters. The optimal MA procedures were selected previously using an already described technique called the bias detection simulation method, considering the ability of bias detection the size of total allowable error as the key parameter for optimization.ResultsDuring 6 months, 17 MA alarms were registered, which is 0.023% of the total number of generated MA values. In 65% of cases, their cause was of pre-analytical origin, in 12% of analytical origin, and in 23% the cause was not found. The highest alarm rate was determined on sodium (0.10%), and the lowest on calcium and chloride.ConclusionsThis paper showed that even in a small-volume laboratory, previously optimized MA procedures could be successfully implemented in the LIS and used for continuous quality control. Review of patient results, re-analysis of samples from the stable period, analysis of internal quality control samples and assessment of the analyser malfunctions and maintenance log have been proposed for the algorithm for managing MA alarms. 相似文献
8.
Ana Nikler Helena i
ak Danijela Bejuk Vanja Radi&#x;i&#x; Biljak Ana-Maria &#x;imundi&#x; 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2022,32(1)
IntroductionThe aims of study were to assess: 1) performance specifications of Atellica 1500, 2) comparability of Atellica 1500 and Iris, 3) the accuracy of both analysers in their ability to detect bacteria.Materials and methodsCarryover, linearity, precision, reproducibility, and limit of blank (LoB) verification were evaluated for erythrocyte and leukocyte counts. ICSH 2014 protocol was used for estimation of carryover, CLSI EP15-A3 for precision, and CLSI EP17 for LoB verification. Comparison for quantitative parameters was evaluated by Bland-Altman plot and Passing-Bablok regression. Qualitative parameters were evaluated by Weighted kappa analysis. Sixty-five urine samples were randomly selected and sent for urine culture which was used as reference method to determine the accuracy of bacteria detection by analysers.ResultsAnalytical specifications of Atellica 1500 were successfully verified. Total of 393 samples were used for qualitative comparison, while 269 for sediment urinalysis. Bland-Altman analysis showed statistically significant proportional bias for erythrocytes and leukocytes. Passing-Bablok analysis for leukocytes pointed to significant constant and minor proportional difference, while it was not performed for erythrocytes due to significant data deviation from linearity. Kappa analysis resulted in the strongest agreements for pH, ketones, glucose concentrations and leukocytes, while the poorest agreement for bacteria. The sensitivity and specificity of bacteria detection were: 91 (59-100)% and 76 (66-87)% for Atellica 1500 and 46 (17-77)% and 96 (87-100)% for Iris.ConclusionThere are large differences between Atellica 1500 and Iris analysers, due to which they are not comparable and can not be used interchangeably. While there was no difference in specificity of bacteria detection, Iris analyser had greater sensitivity. 相似文献
9.
Davide Giavarina Mariarosa Carta 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2015,25(1):64-68
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10.
11.
由于研发人员工作内容的复杂和产出的不确定,如何对其绩效进行科学、准确的测量和管理一直以来困扰着研发管理者。较之于社会标签、工作结果等表层绩效信息,对研发人员日常工作行为的分析研究可以帮助我们更好的理解其深层次绩效特征,进而开展有针对性的绩效管理。因此本文提出了一种基于行为证据推理的研发人员绩效测量方法。这一方法首先确定与研发人员绩效相关的行为证据,进而采集行为数据并利用证据推理规则构建起研发人员“行为-绩效”间的推理关系,进而根据推理结果对研发人员绩效表现进行预测和管理。通过实证研究,上述方法可以有效判断个体研发人员的绩效水平,并帮助研发管理者开展有针对性的绩效反馈、提升。 相似文献
12.
Merica Aralica Vesna &#x;upak Smol
i&#x; Tamara Turk Wensveen Snjeana Hrabri&#x; Vlah Mihael Selar Lidija Bili&#x; Zulle 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2022,32(2)
IntroductionVitamin D testing is excessively used in clinical practice, despite of the clinical guidelines statements against population screening for vitamin D deficiency. This study aimed to assess an annual number of performed 25-hydroxy vitamin D (25(OH)D) tests that were unsupported by the national guidelines for prevention, detection and therapy of vitamin D deficiency in adults and to calculate associated financial burden for the publicly funded healthcare.Materials and methodsA representative sample of requested 25(OH)D tests in 2018 (N = 474) was formed after selection and randomisation of data set (N = 5298) collected from the laboratory information system database of the Clinical Department for Laboratory Diagnostics, the Clinical Hospital Centre Rijeka. Records were classified in two groups depending on associated medical condition(s) according to the national guidelines. An annual cost of the total and group specific vitamin D testing was calculated on the base of a single test price reimbursed by the Croatian Healthcare Insurance Fund (CHIF).ResultsMedical conditions with high-risk for vitamin D deficiency were detected in 43% (206/474) of vitamin D requests (group 1). Conditions not associated with vitamin D deficiency were detected in 57% (268/474) requests (group 2). A total cost of 25(OH)D testing for the CHIF was 58,729.50 EUR (25,523.79 EUR in the group 1 and 33,205.71 EUR in the group 2).ConclusionsMore than half of all 25(OH)D tests performed in the clinical laboratory represent avoidable cost for the public healthcare. Prevention of population screening by vitamin D testing is needed. 相似文献
13.
Philip J. Nickel 《Ethics and Information Technology》2011,13(4):355-363
In this paper, I examine the ethics of e-trust and e-trustworthiness in the context of health care, looking at direct computer-patient interfaces (DCPIs), information systems that provide medical
information, diagnosis, advice, consenting and/or treatment directly to patients without clinicians as intermediaries. Designers,
manufacturers and deployers of such systems have an ethical obligation to provide evidence of their trustworthiness to users.
My argument for this claim is based on evidentialism about trust and trustworthiness: the idea that trust should be based on sound evidence of trustworthiness. Evidence of trustworthiness
is a broader notion than one might suppose, including not just information about the risks and performance of the system,
but also interactional and context-based information. I suggest some sources of evidence in this broader sense that make it
plausible that designers, manufacturers and deployers of DCPIs can provide evidence to users that is cognitively simple, easy
to communicate, yet rationally connected with actual trustworthiness. 相似文献
14.
Simundic AM Lippi G 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2012,22(2):145-149
Preanalytical phase is the most vulnerable part of the total testing process and is considered to be among the greatest challenges to the laboratory professionals. However, preanalytical activities, management of unsuitable specimens and reporting policies are not fully standardized, nor harmonized worldwide. Several standards related to blood sampling and sample transportation and handling are available, but compliance to those guidelines is low, especially outside the laboratory and if blood sampling is done without the direct supervision of the laboratory staff. Furthermore, for some most critical procedures within the preanalytical phase, internationally accepted guidelines and recommendations as well as related quality measures are unfortunately unavailable. There is large heterogeneity in the criteria for sample rejection, the different strategies by which unacceptable samples are managed, processed and test results reported worldwide. Management of unacceptable specimens warrants therefore immediate harmonization. Alongside the challenging and long road of patient safety, preanalytical phase offers room for improvement, and Editors at Biochemia Medica Journal definitely hope to continue providing a respective mean for reporting studies on different preanalytical phase topics. With pleasure and delight we invite potential future authors to submit their articles examining the quality of various preanalytical activities to Biochemia Medica. We will keep nurturing this topic as our prominent feature and by this we hope to be able to deliver valid evidence for some future guidelines and recommendations. 相似文献
15.
16.
17.
Brguljan PM 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2011,21(1):7-11
The practice of medical biochemistry in Slovenia includes clinical biochemistry (including toxicology, therapeutic drug monitoring, endocrinology, molecular diagnostics, immunology), hematology and coagulation. To start the vocational medical biochemistry training programme it's necessary to have a completed university degree (second cycle) in pharmacy, chemistry, biochemistry, medicine or other relevant university study and 1 year supervised practical training in medical laboratories, completed with mandatory state exam at Ministry of Health. The duration of vocational training programme is 4 years and is completed with final exam. The title after passed final examination is Medical biochemistry specialist. In October 2005 EC4 (Communities Confederation of Clinical Chemistry and Laboratory Medicine) approved Equivalence of standards of Slovenian national standards for medical biochemistry specialists. Since 2006 it is mandatory to be registered and to have valid license for medical biochemistry specialists and other professionals in laboratory medicine with at least university degree (second cycle) of education. Laboratory medicine in Slovenia is regulated globally through the Law of health-care activity and particularly through the Bylaw of laboratory medicine. The latter is based on standard ISO 15189, ratified in 2004. The Bylaw envisages granting working license to laboratories, valid for 5 years period. Granting of working licenses is ongoing process and first licenses have been granted in 2009. Important improvement toward the quality requirements for medical laboratories can be observed in the last 5 years. Parallel with the Bylaw of medical laboratories, Slovenian Accreditation (SA), the legal national accreditation body, started the initiative for accreditation of medical laboratories according to ISO 15189. It is in the implementation phase. 相似文献
18.
Lara Milevoj Kop
inovi&#x; Gordana Juri
i&#x; Adriana Bokuli&#x; Ines Vukasovi&#x; Ivana &#x;elap Helena i
ak Marija Kocijan
i&#x; Marija Milo&#x; Mila Lovri&#x; Marija Siter Kupre&#x;anin Snjeana Hrabri&#x; Vlah Manuela Mileti&#x; 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2022,32(2)
IntroductionThe aim of this study was to screen practices used in verification procedures for methods/analysers among medical biochemistry laboratories (MBLs) in Croatia. We hypothesized that these procedures differ widely from laboratory to laboratory and wanted to gather specific data on steps used in the verification workflow.Materials and methodsIn order to obtain data, an online survey was conducted. The survey, divided in two sections, contained 29 questions and statements addressing general characteristics and specific steps of the verification workflow of each individual MBL. The survey was disseminated among managers of all MBLs in Croatia.ResultsA total of 108/196 (55%) laboratories participated in the survey. Forty nine MBLs were excluded from the second part of the survey: 14 have not implemented verification procedures, and 35 MBLs due to the absence of answers. The most relevant results of the second part of the survey showed that: 18/59 (0.31) of the responding MBLs have difficulties when defining acceptance criteria, 27/59 (0.46) used the Clinical and Laboratory Standards Institute protocol for precision estimation; the majority of MBLs used a median of 20 samples for method/analyser comparisons and estimated bias using internal quality control samples; reference intervals provided by external sources are mainly adopted; 60% of MBLs do not include linearity verification in their protocol and do not use the national document for the estimation of measurement uncertainty.ConclusionsHeterogeneous verification protocols are routinely utilized across Croatian MBLs which clearly confirms that a national document might help in the harmonization of verification procedures. 相似文献
19.
Winterhalter-Jadrić M Causević A Jadrić R Corić J Hasić S Kiseljaković E 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2011,21(1):12-14
In this paper we would like to briefly introduce readers to the situation in the field of laboratory medicine in Bosnia and Herzegovina, with a focus on training in the field of medical biochemistry. As in some of neighboring countries, term Medical biochemist is the usual name for the Clinical biochemist or Clinical chemist in Bosnia and Herzegovina. Despite the difficult period through which the profession had passed in the last two decades, laboratory work, particularly clinical biochemistry, has managed to retain the necessary quality and keep pace with the developed world. In post war period, Society of Medical Biochemists of Bosnia and Herzegovina held regular meetings each year as a part of "life long learning" process, where both scientific and vocational lecturers presented their work. A single law on the state level would provide us with more defined and precise answers, such as: who can get a specialization, how long should last the training for medical biochemistry specialists (duration in years). This law should be in consent with the program described in EC4 or other documents given by the EFCC (European Federation of Clinical Chemistry and Laboratory Medicine) and IFCC (International Federation of Clinical Chemistry and Laboratory Medicine). 相似文献
20.
Pilar Fernandez-Calle Sandra Pelaz Paloma Oliver Maria Jose Alcaide Ruben Gomez-Rioja Antonio Buno Jose Manuel Iturzaeta 《Biochemia medica : ?asopis Hrvatskoga dru?tva medicinskih biokemi?ara / HDMB》2013,23(1):83-95