Incidents in Molecular Pathology: Frequency and Causes During Routine Testing

Context.— Errors in laboratory medicine could compromise patient safety. Good laboratory practice includes identifying and managing nonconformities in the total test process. Varying error percentages have been described in other fields but are lacking for molecular oncology. Objectives.— To gain insight into incident causes and frequency in the total test process from 8 European institutes routinely performing biomarker tests in non-small cell lung cancer and colorectal cancer. Design.— All incidents documented in 2018 were collected from all hospital services for pre-preanalytical entries before the biomarker test, as well as specific incidents for biomarker tests. Results.— There were 5185 incidents collected, of which 4363 (84.1%) occurred in the pre-preanalytical phase (all hospital services), 2796 of 4363 (64.1%) related to missing or incorrect request form information. From the other 822 specific incidents, 166 (20.2%) were recorded in the preanalytical phase, 275 (33.5%) in the analytical phase, and 194 (23.6%) in the postanalytical phase, mainly due to incorrect report content. Only 47 of 822 (5.7%) incidents were recorded in the post-postanalytical phase, and 123 (15.0%) in the complete total test process. For 17 of 822 (2.1%) incidents the time point was unknown. Pre-preanalytical incidents were resolved sooner than incidents on the complete process (mean 6 versus 60 days). For 1215 of 5168 (23.5%) incidents with known causes a specific action was undertaken besides documenting them, not limited to accredited institutes. Conclusions.— There was a large variety in the number and extent of documented incidents. Correct and complete information on the request forms and final reports are highly error prone and require additional focus.

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Pre-Analytical Workstations as a Tool for Reducing Laboratory Errors

Journal of Medical Biochemistry ◽

10.2478/v10011-010-0031-x ◽

2010 ◽

Vol 29 (4) ◽

pp. 315-324 ◽

Cited By ~ 3

Author(s):

Giorgio Rin

Keyword(s):

Quality Improvement ◽

Clinical Laboratory ◽

Error Reduction ◽

Laboratory Errors ◽

Continuous Quality ◽

Complex Process ◽

Preanalytical Phase ◽

Analytical Phase ◽

Total Testing Process

Pre-Analytical Workstations as a Tool for Reducing Laboratory ErrorsReducing errors and improving quality are an integral part of Laboratory Medicine. Laboratory testing, a highly complex process commonly called the total testing process (TTP), is usually subdivided into three traditional (pre-, intra-, and post-) analytical phases. A series of papers published from 1989 drew the attention of laboratory professionals to the pre-analytical phase, which currently appears to be more vulnerable to errors than the other phases. Consequently, the preanalytical phase should be the main target for further quality improvement. Therefore, identifying the critical steps in the pre-analytical phase is a prerequisite for continuous quality improvement, further error reduction and thus for improving patient safety. Use of automated systems where feasible, and use of error reduction/improved quality as a factor when selecting instrumentation are the main tools we have to insure high quality and minimize errors in the pre-analytical phase. The reasons for automation of the pre-analytical phase have become so compelling that it is no longer simply a competitive advantage for laboratories, but rather a competitive necessity. These systems can impact on the clinical/laboratory interface and affect the efficiency, effectiveness and quality of care.

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Order of blood draw: Opinion Paper by the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase (WG-PRE)

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2016-0426 ◽

2017 ◽

Vol 55 (1) ◽

pp. 27-31 ◽

Cited By ~ 31

Author(s):

Michael Cornes ◽

Edmée van Dongen-Lases ◽

Kjell Grankvist ◽

Mercedes Ibarz ◽

Gunn Kristensen ◽

...

Keyword(s):

Working Group ◽

Clinical Chemistry ◽

Venous Blood ◽

Laboratory Medicine ◽

European Federation ◽

Blood Collection ◽

Sample Collection ◽

Blood Draw ◽

Preanalytical Phase ◽

Analytical Phase

AbstractIt has been well reported over recent years that most errors within the total testing process occur in the pre-analytical phase (46%–68.2%), an area that is usually outside of the direct control of the laboratory and which includes sample collection (phlebotomy). National and international (WHO, CLSI) guidelines recommend that the order of draw of blood during phlebotomy should be blood culture/sterile tubes, then plain tubes/gel tubes, then tubes containing additives. This prevents contamination of sample tubes with additives from previous tubes that could cause erroneous results. There have been a number of studies recently looking at whether order of draw remains a problem with modern phlebotomy techniques and materials, or it is an outdated practice followed simply because of historical reasons. In the following article, the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PRE) provides an overview and summary of the literature with regards to order of draw in venous blood collection. Given the evidence presented in this article, the EFLM WG-PRE herein concludes that a significant frequency of sample contamination does occur if order of draw is not followed during blood collection and when performing venipuncture under less than ideal circumstances, thus putting patient safety at risk. Moreover, given that order of draw is not difficult to follow and knowing that ideal phlebotomy conditions and protocols are not always followed or possible, EFLM WG-PRE supports the continued recommendation of ensuring a correct order of draw for venous blood collection.

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Use of quality indicators to compare point-of-care testing errors in a neonatal unit and errors in a STAT central laboratory

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2013-1053 ◽

2015 ◽

Vol 53 (2) ◽

Cited By ~ 13

Author(s):

Miguel Cantero ◽

Maximino Redondo ◽

Eva Martín ◽

Gonzalo Callejón ◽

María Luisa Hortas

Keyword(s):

Quality Indicators ◽

Point Of Care ◽

Sample Volume ◽

Error Rates ◽

Internal Quality ◽

Central Laboratory ◽

Point Of Care Testing ◽

Patient Identification ◽

Preanalytical Phase ◽

Analytical Phase

AbstractPoint-of-care testing (POCT), like other laboratory tests, can be affected by errors throughout the total testing process. To evaluate quality error rates, the use of quality indicators (QIs) is recommended; however, little information is available on the quality error rate associated with POCT. The objective of this study was to investigate quality error rates related to POCT and compare them with central laboratory (CL) testing.We studied standardized QIs for POCT in comparison to CL testing. We compared error rates related to requests, collection, and handling of samples and results from external quality assessment program (EQAP) and internal quality control (IQC).The highest difference between POCT and CL testing was observed for QI related to patient identification, 45.3% vs. 0.02% (p<0.001). Regarding specimen collection and handling, the QI related to samples without results was also higher in POCT than in CL testing, 15.8% vs. 3.3% (p<0.001). For the QI related to insufficient sample volume, we obtained 2.9% vs. 0.9% (p=0.27). Unlike QIs for the preanalytical phase, QIs for the analytical phase had better results in POCT than CL testing. We obtained 8.3% vs. 16.6% (p=0.13) for QI related to unacceptable results in EQAP and 0.8% vs. 22.5% (p<0.001) for QI related to unacceptable results in IQC.Our results show that the preanalytical phase remains the main problem in POCT like in CL testing and that monitoring of quality indicators is a very valuable tool in reducing errors in POCT.

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Test Cancellation: A College of American Pathologists Q-Probes Study

Archives of Pathology & Laboratory Medicine ◽

10.5858/arpa.2015-0022-cp ◽

2016 ◽

Vol 140 (2) ◽

pp. 125-129 ◽

Cited By ~ 6

Author(s):

Teresa P. Darcy ◽

Samuel P. Barasch ◽

Rhona J. Souers ◽

Peter L. Perrotta

Keyword(s):

Patient Care ◽

Laboratory Services ◽

Preanalytical Phase ◽

Specimen Volume ◽

Cancellation Rate ◽

Specimen Quality ◽

Impact Patient Care ◽

Lower Test ◽

Analytical Phase ◽

Test Request

Context Requests for laboratory testing are canceled after a specimen has already been collected from the patient for many reasons. Regardless of the cause, test cancellation represents a significant resource expenditure for laboratories, and many cancellation events impact patient care by delaying the reporting of test results. Objective To survey a wide variety of hospitals to determine the rate, causes, and circumstances surrounding laboratory test cancellation events. Design Institutions (N = 52) prospectively monitored their test cancellation events during a 6-week period or until 75 cancellation events occurred. Information regarding the test cancellation was recorded, including the primary reason for canceling the test. The rate of test cancellation was calculated based on laboratory specimen volume. Laboratory policies relevant to test cancellation were also surveyed. Results A total of 3471 canceled tests were recorded by participating laboratories of 1 118 845 specimens they accessioned, resulting in an aggregate test cancellation rate of 3.1 per 1000 accessions. The most frequently reported reason for test cancellation occurred in the preanalytical phase, and was a duplicate test request, followed by specimen quality reasons including hemolyzed/clotted specimens and insufficient sample quantity for testing. Very few cancellations occurred during the analytical phase of testing. Lower test cancellation rates were reported by larger institutions and by laboratories that received fewer specimens from inpatients. Conclusions Cancellation of patient tests after a specimen had been collected and received remains a significant issue for clinical laboratories. Laboratories should monitor causes of test cancellation to identify targets for process improvement efforts and to improve laboratory utilization. Cancellation events due to incomplete identification or poor specimen quality potentially delay patient care. Cancellations due to duplicate orders or excessive frequency of testing represent operational challenges for the laboratory and inefficiency in the health care system. Policies related to test cancellation should be clearly specified and communicated to users of laboratory services.

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Analysis, detection and quantitation of mixed cryoglobulins in HCV infection: brief review and case examples

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2015-1143 ◽

2016 ◽

Vol 54 (12) ◽

Cited By ~ 3

Author(s):

Chesinta B. Voma ◽

Stanley S. Levinson

Keyword(s):

Good Reason ◽

Mixed Cryoglobulinemia ◽

Hcv Infection ◽

Accurate Identification ◽

Case Examples ◽

Detection Analysis ◽

Preanalytical Phase ◽

High Incidence ◽

Clear Identification ◽

Analytical Phase

AbstractConsidering the high incidence of cryoglobulins in hepatitis C virus (HCV) infection together with the high worldwide prevalence of HCV infection, identification of clinically apparent mixed cryoglobulinemia syndrome is increasingly important as most patients who are identified can now be successfully treated. Different approaches for the detection, analysis and reporting of cryoglobulins have been described and there is a wide variation in results reported, ranging from a qualitative “negative” or “positive”, to a quantitative report including cryoglobulin type and the total protein. Protein and immunofixation (IFE) electrophoresis are generally used to identify and characterize cryoglobulins, as these methods quantify and phenotype. Here, we present a brief review of the literature and demonstrate a case oriented approach for identifying mixed cryoglobulinemia from the preanalytical phase, leading up to and including the analytical phase with characterization by IFE. Most patients with mixed cryoglobulinemia can now be treated with success. Nevertheless, the high cost may limit treatment of those with symptoms unless there is laboratory evidence for mixed cryoglubulinemia. Low levels of cryoglobulins can be associated with severe symptoms; as a result, accurate identification of cryoglobulins may be of increasing importance since clear identification may be a good reason to initiate treatment.

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COMPARISON OF INCIDENCE OF PRE-ANALYTICAL PHASE ERRORS IN OPD AND IPD SAMPLES IN A SUPER-SPECIALTY HOSPITAL: A RETROSPECTIVE STUDY

International Journal of Advanced Research ◽

10.21474/ijar01/11990 ◽

2020 ◽

Vol 8 (11) ◽

pp. 171-174

Author(s):

Gurpreet Singh Battu ◽

◽

Amitoj Singh Battu ◽

Sumeet Sidhu

Keyword(s):

Retrospective Study ◽

Nursing Staff ◽

Phase Error ◽

The Other ◽

Sample Collection ◽

Phase Errors ◽

Preanalytical Phase ◽

Multiple Tasks ◽

Specialty Hospital ◽

Analytical Phase

Objective: To evaluate and compare the incidence of errors in pre-analytical phase in OPD and IPD samples. Multitude of human involvement in preanalytical processes makes this phase error prone. Analysis of the same can help in assessing the magnitude and planning the corrective steps. Methodology: Study was conducted retrospectively for the period July 2019 to June 2020. Samples collected from OPD sample collection room and different areas of IPD were scrutinized for pre-defined errors. Number of errors in OPD and IPD were statistically compared. Results: 679 samples out of 50713 (1.3%) OPD samples in the study period had one error or the other. Similarly, 1533 samples out of 87525 (1.7%) IPD samples had errors. When compared statistically, this difference is highly significant. (p < 0.00001). Conclusion: IPD samples are more prone to errors for the fact that these samples are collected by nursing staff or resident doctors in the different areas of the hospital. This staff is involved in patient care and has to look after multiple tasks, hence chances of error are more. OPD samples are collected by the same team, who are trained phlebotomists and are in constant touch with lab. Thus OPD samples have less preanalytical phase errors.

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Hubungan Antara Anemia dan Kebiasaan Merokok pada Ibu Hamil dengan Kejadian BBLR di Rumah Sakit Umum Pusat Dr. Mohammad Hoesin Palembang Tahun 2016

SRIWIJAYA JOURNAL OF MEDICINE ◽

10.32539/sjm.v1i2.13 ◽

2018 ◽

Vol 1 (2) ◽

pp. 89-94

Author(s):

Intan Sari

Keyword(s):

Birth Weight ◽

Low Birth Weight ◽

General Hospital ◽

Smoking Habit ◽

Complete Information ◽

Developed Countries ◽

Statistical Test ◽

Survey Method ◽

Bivariate Analysis ◽

Cross Sectional

Low Birth Weight (LBW) is an infant born with a birth weight of less than 2500 grams regardless of gestation. Birth weight is the weight of the baby weighed in 1 hour after birth. (Depkes RI, 2009). Based on WHO and UNICEF data, in 2013 about 222 million babies were born in the world, of which 16% were born with low birth weight. The percentage of LBW in developing countries is 16.5% twice that of developed countries (7%) (Scholar Unand, 2014). The purpose of this study was to determine whether there is a relationship between anemia and Smoking Habit in Pregnant Women with LBW occurrence in General Hospital Dr. Mohammad Hoesin Palembang Year 2016. This research use analytical survey method with cross sectional approach. The population in this study were all mothers who gave birth monthly in Midwifery Installation of Dr. General Hospital Mohammad Hoesin Palembang in 2016 as many as 315 respondents. The sample of this research is some of mothers who give birth enough month in Midwifery Installation of Dr. General Hospital Mohammad Hoesin Palembang Year 2016 as many as 315 respondents. ". From the results of bivariate analysis of anemic respondents with the occurrence of LBW obtained statistical test X2 count = 23.22 which means there is a significant relationship between anemia with the incidence of BBLR. Respondents smoking with the occurrence of LBWR obtained statistical test X2 count = 41.20 which means there is a relationship Meaningful between smoking and LBW incidence. From the results of this study is expected that this research can be a reference material and is a complete information and useful for the development of knowledge about LBW.

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