Clinical Laboratory Processes Research Articles

Quality of care and patient safety in the clinical laboratory process

This study is part of a result of the research project Prevention and control of adverse events in the pre-analytical phase of the clinical laboratory process at the Hospital León Becerra of Guayaquil. It is focused on offering a theoretical, analytical and comparative contribution of previous research carried out at the León Becerra Hospital in Guayaquil. Principle of the form The general objective of this work is to evaluate the quality of care in the clinical laboratory processes of different studies and to provide feedback for the quality of care and patient safety in the clinical laboratory process.

Integration technologies in laboratory information systems: A systematic review

Clinical laboratories have evolved with technological advancements through integrating various subsystems into Health Information Systems (HIS), particularly the Laboratory Information System (LIS). The LIS automates processes, manages results, and interfaces with healthcare information sources. Challenges include workflow inefficiencies and data interpretation issues. Despite increased data accessibility, managing clinical data across systems remains complex. Integrating laboratory machines into LIS is essential for optimizing healthcare delivery, requiring effective integration technologies. This study aims to synthesize the existing empirical studies on the utilization of integration technologies for Software-to-Software (S2S) communication in automating clinical laboratory processes. This study systematically examined integration technologies in LIS using PubMed and following PRISMA 2020 guidelines. The three-phase methodology included a scoping analysis, methodological analysis, and a gap analysis, focusing on S2S communication, interoperability frameworks, data standards, communication protocols, and challenges in LIS integration technologies. Analysis of 28 sample studies revealed a complex landscape in LIS integration shaped by end-users, care providers, and researchers. Clinical laboratories prioritize integration, focusing on patient data and sustainability. Standards like HL7 and FHIR ensure interoperability. Eleven methodologies highlight system development in Health Information Systems (HIS). Interoperability is a common objective, with 22 out of 28 studies achieving success. Challenges include limited generalizability, poor validation, and post-implementation modifications. Issues like security, data incompatibility, and evolving standards persist.

Analytical validation of automated multiplex chromogenic immunohistochemistry for diagnostic and predictive purpose in non-small cell lung cancer

ObjectivesThe evaluation of an increasing number of diagnostic and predictive markers is playing a central role in precision thoracic oncology. Multiplex immunohistochemistry (mIHC), alongside next-generation sequencing, is ideally situated for this purpose and maximizes tumor tissue preservation for molecular analyses that use increasingly large panels. However, the standardization and validation of mIHC that supports routine clinical laboratory processes are mandatory. After a previous proof-of-concept study, we now (i) optimized two automated four-plex assays on a commercially available IHC autostainer for use in daily practices worldwide and (ii) evaluated the repeatability and concordance of the assessment of the cell density. Patients and methodsTwo four-plex mIHC assays [i) TTF1, p40, PD-L1, CD8; and, ii) ALK, ROS1, BRAFV600E, NTRK] were optimized on the BenchMark ULTRA autostainer (Ventana Medical Systems, Inc.), as determined in comparison to conventional IHC chromogenic assays. Intra-site repeatability was evaluated on serial tumor sections from non-small cell lung carcinomas (NSCLC). The concordance was assessed by linear fit to plots of the percentage staining evaluated on tumor sections from 89 NSCLC patients. ResultsFollowing optimization, an average concordance for a staining rate of 95.4% was achieved between conventional IHC and mIHC across all selected markers. Assessment of intra-site repeatability showed strong concordance for all these markers (average, R2 = 0.96; P-value < 0.001). ConclusionsOur optimized mIHC assay gave a sensitive and repeatable assessment of two panels of eight diagnostic and predictive biomarkers for NSCLC. The availability of standardized protocols to determine these biomarkers on a widely available IHC platform will expand the number of pathology laboratories able to determine the eligibility of patients with NSCLC for targeted treatment or immunotherapy in a reliable and concordant manner, thus providing a unique sample-sparing tool to characterize limited tissue samples in thoracic oncology.

Detecting Preanalytical Errors Using Quality Indicators in a Hematology Laboratory.

Background and Objectives:Monitoring laboratory performance continuously is crucial for recognizing errors and fostering further improvements in laboratory medicine. This study aimed to review the quality indicators (QIs) and describe the laboratory errors in the preanalytical phase of hematology testing in a clinical laboratory.Methods:All samples received in the Hematology Laboratory of the Maternity and Pediatric Hospital in Hail for 3 years were retrospectively reviewed and evaluated for preanalytical issues using a set of QIs. The rate of each QI was compared to the quality specifications cited in the literature.Results:A total of 95002 blood samples were collected for analysis in the hematology laboratory from January 2017 through December 2019. Overall, 8852 (9.3%) were considered to show preanalytical errors. The most common were “clotted specimen” (3.6%) and “samples not received” (3.5%). Based on the quality specifications, the preanalytical QIs were classified generally as low and medium level of performance. In contrast, the sigma-based performance level indicates acceptable performance on all the key processes. Further analysis of the study showed a decreasing rate of preanalytical errors from 11.6% to 6.5%.Conclusions:Preanalytical errors remain a challenge to hematology laboratories. The errors in this case were predominantly related to specimen collection procedures that compromised the specimen quality. Quality indicators are a valuable instrument in the preanalytical phase that allows an opportunity to improve and explore clinical laboratory process performance and progress. Continual monitoring and management of QI data are critical to ensure ongoing satisfactory performance and to enhance the quality in the preanalytical phase.

Multi-institutional TSA-amplified Multiplexed Immunofluorescence Reproducibility Evaluation (MITRE) Study

BackgroundEmerging data suggest predictive biomarkers based on the spatial arrangement of cells or coexpression patterns in tissue sections will play an important role in precision immuno-oncology. Multiplexed immunofluorescence (mIF) is...

A Daily Operational Huddle and a Real-Time Communication Application Improve Efficiency of Laboratory Processes.

Clinical laboratory processes that require cooperation among geographically distinct sections often face challenges. We describe these challenges as related to the Gram staining of cerebrospinal fluid, a key test in the management of patients with suspected central nervous system infections, and our attempts to improve quality outcomes. To evaluate multiple tools and strategies for their effectiveness in optimizing the turnaround time of tests sharing a specimen or workflow. Over the course of 5 years, the turnaround time of cerebrospinal fluid Gram stain was studied at one of the largest children's health systems in the United States. Baseline data showed suboptimal compliance to targeted turnaround times. A conventional approach to process standardization and 2 innovative tools that facilitate horizontal integration were applied to the main campus laboratory as follows: a daily operational huddle and a novel electronic communication application that was interfaced with the laboratory information system. Turnaround time and its variation were assessed. Two other hospital laboratories within the health system that did not undergo these quality interventions served as controls. Standardization of processes reduced the variability of turnaround time but only minimally shortened it. In contrast, an interteam daily huddle that monitored key quality metrics together with the communication application improved turnaround time significantly and sustainably. Communication strategies involving a physical or virtual gathering of laboratory representatives encourage horizontal communication and improve turnaround times. These tools are generally applicable and could be used to improve other processes in healthcare, especially those where a workflow is shared between 2 geographically distinct areas of a health system.

Sigma Metrics: A Powerful Tool for Performance Evaluation and Quality Control Planning in a Clinical Biochemistry Laboratory

Introduction: Any error in the laboratory testing processes can affect the diagnosis and patient management. Six Sigma is a data driven quality management system for identifying and reducing errors and variations in clinical laboratory processes. Aim: This study was carried out to estimate Sigma metrics of various biochemical analytes in order to evaluate performance of quality control and implement optimum quality control strategy for each analyte. Quality goal index (QGI) was also calculated to identify the problems of inaccuracy and imprecision for parameters having lower sigma values. Materials and Methods: This retrospective, observational study was conducted at the Central Clinical Biochemistry Laboratory of Seth GS Medical College and KEM hospital in Mumbai for a period of six months (July 2019 to December 2019). Sigma metrics for 20 analytes was calculated by using internal quality control and external quality control data. Further, QGI was calculated for analytes having sigma value of &lt;4 to identify imprecision or inaccuracy. Statistical analysis was performed using Microsoft office excel 2010 software. Results: Total protein, Glucose, Urea, Triglyceride (TAG), High Density Lipoprotein (HDL), and Low Density Lipoprotein (LDL) for normal (L1) and pathological (L2) controls achieved excellent performance (&gt;6 sigma). Westgard rule (13s) with two control measurement (N2) per QC event and run size (R1000) i.e. 1000 patient samples between consecutive QC events was adopted for these analytes. For analytes with sigma value of 4-6, more rules (sigma 4-5: Westgardrules-13s/22s/R4s/41s, N4 and R200 and for sigma value 5-6: 13S/22s/R4s, N2 and R450) were adopted. The sigma values of six analytes (Creatinine, Sodium, Potassium, Calcium, Chloride, Inorganic phosphate) were &lt;4 at one or more QC levels. For these analytes, strict QC procedures (Westgard rules-13s/22s/R4s/41s/6x, N4 and R45) were incorporated. QGI of these analytes was &lt;0.8 which indicated the problem of imprecision. Staff training programs and review of standard operating procedures were done for these analytes to improve method performance. Conclusion: Sigma Metrics estimation helps in designing optimum QC protocols, minimising unnecessary QC runs and reducing the cost for analytes having high sigma metrics. Focused and effective QC strategy for analytes having low sigma helps in improving the performance of those analytes.

Quality management in clinical laboratories: application of six sigma protocol

Amaç: Bu çalışmada kalite yönetim aracı olan altı sigma protokolü kullanılarak klinik laboartuvar süreçlerindeki iyileştirici etki düzeylerinin belirlenip sağladığı pozitif katkıların ortaya konulması amaçlanmıştır.Gereç ve Yöntem: Bu çalışmada; Çukurova Üniversitesi Tıp Fakültesi Balcalı Sağlık Uygulama ve Araştırma Merkezi-Merkezi Laboratuvarı’nda oluşan hataların sınıflandırılması, nedenlerinin araştırılması ve yöntem performanslarının değerlendirilmesi için “Altı Sigma Protokolü” uygulanmıştır. Evrensel standartlarda çalışabilmek için hataların kaynağı ve sıklığının analizi yapılarak öncelikle mevcut durum tespit edilmiştir. Oluşan hataların saptanması ve sınıflandırılması sonucunda, en çok etkilenen süreçlerden başlanarak, düzeltici faaliyetler planlanmıştır. Bulgular: Preanalitik evre hata sayısı sigma düzeylerinin 4,250-4,357’den 4,500-4,625’e yükseldiği bulunmuştur. Analitik evrede en yüksek sigma düzeyinin amilaz testi için 10,5 olduğu görülmüştür. Postanalitik evrede ise; potasyum test istek sonuç süresi sigma düzeyinin süreç sonunda 2,250’den 2,500’e yükseldiği belirlenmiştir. Sonuç: Bu çalışma; hasta sağlığına olumsuz yansıyabilecek hataların giderilmesine, hasta memnuniyetine, uygun internal kalite kontrol kurallarının seçilmesine olanak sağlamıştır. Düzeltici faaliyetler ve alınan önlemler doğrultusunda kaliteli hizmetin bir maliyeti olmasına karşın kalitesizlik maliyetleri azaltılmıştır. Laboratuvar performansının evrensel ölçütlerde hesaplanarak, dünyadaki diğer klinik laboratuvarlar ile performans karşılaştırması da 4-5 üzerinde olması evrensel kalite standartlarında hizmet verdiğimizi teyit etmiştir.

The results of a close follow-up of trainees to gain a good blood collection practice.

Phlebotomy is one of the most important steps in the preanalytical phase of a clinical laboratory process. In order to decrease phlebotomy errors, this specific procedure should be taught in detail by laboratory organizations. Our study aims to practice the training program on venous blood sampling and observe the close follow-up results. In this observational study, 127 students who started their summer internship in Antalya Education and Research Hospital were given a one-day theoretical phlebotomy training in accordance with the Venous Blood Sampling Guidelines. After the theoretical training, phlebotomy applications of 10 students who were working in the field of out-patient blood sampling were observed both with and without their knowledge. A comprehensive checklist related to phlebotomy was created by the trainers in Antalya Education and Research Hospital and the observers answered each question as yes or no. For the statistical analysis, IBM SPSS Statistics 21.0 was used. After the theoretical education, the trainees were observed but no significant difference was found between the first and the second informed observations (p = 0.125). The students were observed three times more in the following week without their knowledge. There was a statistically significant difference between the first and the third unannounced observations (p=0.001). In order to perform phlebotomy correctly, apart from theoretical education, a close follow-up is necessary too.

Abstract LB-318: Multi-institutional TSA-amplified Multiplexed Immunofluorescence Reproducibility Evaluation (MITRE study): Reproducibility assessment of an automated multiplexed immunofluorescence slide staining, imaging, and analysis workflow

Abstract Background: Emerging data suggests that predictive biomarkers based on the spatial arrangement of multiple cell types in FFPE tissue sections will be an important component of precision medicine in immune-oncology. Multiplexed immunofluorescence (mIF) facilitates such assessments. If mIF is to play a translational role in research and ultimately clinical practice, it is vital to refine, standardize, and validate an end-to-end workflow that supports large scale multi-site trials and clinical laboratory processes. To this end, six institutions collaborated to develop an automated 6-plex assay focused on the PD-1/PD-L1 axis and assessed its inter- and intra-site reproducibility. Specific attention was paid to assessment of %PD-L1 expression by immune cells (ICs), as pathologists have poor concordance for this parameter as noted in the Blueprint 2 and multi-institutional NCCN studies on PD-L1 IHC. Methods: A 7-color mIF panel (PD-L1, PD-1, CD8, CD68, FoxP3, Cytokeratin, and DAPI) was optimized on a Leica Bond Rx autostainer. Serial sections of tonsil and a lung cancer tissue-microarray (TMA), antibodies and TSA-Opal detection reagents (Akoya Biosciences) were distributed. Cell pellet arrays were also distributed and used to normalize batch variation in intensity measurements. Tonsil and TMA sections were stained at each site and imaged at 20x using a Vectra Polaris. Cells were segmented and phenotyped using image analysis algorithms. In tonsil sections, the average intensity of the top quartile of cells positive for each marker was assessed to identify potential variation in staining intensity. In lung TMAs, cell densities and %PD-L1 expression in immune cells (CD68+ and CD8+ cells) was determined. Results: The average staining intensity coefficients of variation (CV) for all markers within sites was 10% in tonsil samples. Inter-site concordance for tumor cell and immune cell subset densities in TMAs, had an average R2 value of 0.86 and slope of 0.96. Inter-site concordance for %PD-L1+ ICs had an average R2 value of 0.81, and slope of 0.82, in contrast to ICC values of &amp;lt;0.3 in the NCCN and Blueprint 2 studies. Conclusions: We demonstrate a reproducible end-to-end process for mIF characterization of the PD-1/PD-L1 axis including automated staining, multispectral imaging, and machine-learning-trained image analysis algorithms. This approach improved reproducibility of %PD-L1 IC assessment and brought it in line with %PD-L1 tumor cell assessment by pathologists. Sources of variation were identified and will be discussed. The described approach may serve as a template for assessing reproducibility of emerging mIF panels for other investigative teams, with an eye toward translating such approaches into clinical trials and ultimately into the clinic. Citation Format: Clifford Hoyt, Kristin Roman, Liz Engle, Chichung Wang, Carmen Ballesteros-Merino, Shawn M. Jensen, John McGuire, Yi Zheng, Carla Coltharp, Mei Jiang, Justin Lucas, Edwin Parra, Ignacio Wistuba, Darren Locke, Bernard A. Fox, David L. Rimm, Janis Marie Taube. Multi-institutional TSA-amplified Multiplexed Immunofluorescence Reproducibility Evaluation (MITRE study): Reproducibility assessment of an automated multiplexed immunofluorescence slide staining, imaging, and analysis workflow [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr LB-318.

Plasma lactate measurement as an example of encountered gaps between routine clinical laboratory processes and manufactures' sample-handling instructions

ObjectivesDeviation from manufacturers’ pre-analytical sample handling recommendations necessitates extensive validation studies. This report uses plasma lactate testing, where a recommended 15 min room temperature sample handling limit cannot be met by the clinical laboratory, as an example for studies to bridge the gap with practice. Design and MethodsTriplicate blood samples were collected from patients (n = 51) with lactate requests by clinicians and from normal volunteers (n = 50). One tube was transported on ice (4 °C), the others were maintained at room temperature (23 °C). Tubes stored at 4 °C were processed at 30 min from collection. Tubes stored at 23 °C were processed at 15 and at 30 min from collection. Lactate levels were measured using Roche Diagnostics Cobas 6000® analyzer. ResultsLactate levels in normal subjects ranged from 0.6 to 3.1 mmol/L (median 1.1). Patient lactate levels ranged from 0.8 to 26.3 mmol/L (median 2.2). Bias in lactate levels following extended storage of samples from both normal subjects and patients ranged from − 1.3 to2.2 and from − 1.0–1.0 mmol/L when stored for 30 min at 23 °C or at 4 °C, respectively. The bias between lactate levels at 30 min at 23 °C and 4 °C was − 1.2 to − 0.5 mmol/L for both populations. Although the bias was not statistically significant for all variables, a clinically significant (>0.2 mmol/L) bias was observed in 28% of normal and 7.0% of patient samples. ConclusionExtending the pre-analytical time to 30 min at 23 °C did not significantly impact clinical utility of lactate measurement in our patient population.

Standardization Can Accelerate the Adoption of Pharmacogenomics: Current Status and the Path Forward

Successfully implementing pharmacogenomics into routine clinical practice requires an efficient process to order genetic tests and report the results to clinicians and patients. Lack of standardized approaches and terminology in clinical laboratory processes, ordering of the test and reporting of test results all impede this workflow. Expert groups such as the Association for Molecular Pathology and the Clinical Pharmacogenetics Implementation Consortium have published recommendations for standardizing laboratory genetic testing, reporting and terminology. Other resources such as PharmGKB, ClinVar, ClinGen and PharmVar have established databases of nomenclature for pharmacogenetic alleles and variants. Opportunities remain to develop new standards and further disseminate existing standards which will accelerate the implementation of pharmacogenomics.

Computer-assisted interventions in the clinical laboratory process improve the diagnosis and treatment of severe vitamin B12 deficiency.

Severe vitamin B12 deficiency can result in serious complications if undiagnosed or untreated. Our aim was to test the efficacy of interventions in the laboratory process to improve the detection and the treatment of severe vitamin B12 deficiency. Quasi-experimental investigation with a retrospective 7-year pre-intervention period and 29-month post-intervention follow-up in a university hospital. Two interventions were designed to improve the detection and treatment of subjects with vitamin B12 deficiency: the laboratory information system (LIS) automatically added seru vitamin B12 (s-vitamin B12) based on certain conditions; and created a comment in the report and scheduled an appointment with the general practitioner (GP). We calculated the number of new diagnoses of severe vitamin deficiency (s-vitamin B12 <73.8 pmol/L) and the proportion of identified patients that were correctly treated in the pre- and post-intervention periods. We compared the number of tests needed to detect a new case when ordered by GPs vs. added by the strategy. Finally, we investigated the economic cost of each new case. The strategy added 699 s-vitamin B12 and detected 66 new cases of severe vitamin deficiency. The number of tests needed to identify a new case when s-vitamin B12 was ordered by GPs was 187, as opposed to 10 when added through the intervention (p<0.001). The intervention reagent cost was €26.7 per new case. In the post-intervention cohort, 88% of patients were correctly treated, as opposed to 52% in the pre-intervention (p<0.001). Interventions in the clinical laboratory process improved the diagnosis and treatment of severe vitamin B12 deficiency.

Análisis modal de fallos y efectos en la fase pretécnica del Laboratorio de Reproducción

IntroductionIn clinical laboratory processes, the greatest number of errors usually occur in the non-technical phases, performed before and after the technical process. Failure modes and effects analysis (FMEA) is a method for managing potential failures and identifying their effects so that preventive and remedial measures may be proposed. This paper describes a FMEA conducted on the pre-technical phase of work in an assisted reproduction laboratory. Material and methodsA multidisciplinary team drew up a list of possible failures in the activities involved in the pre-technical phase (request, preparation of the patient, collection, manipulation, identification, and transport). These items were evaluated by 17 staff members and users of the assisted reproduction laboratory to determine the potential impact on patient care of each such failure. Indices of severity, probability of occurrence, detection, and overall risk were calculated for each possible failure. ResultsThe possible failures with the highest risk indices were, for the analysis function, illegible request and incorrect manipulation in the use of resources and/or techniques. For the areas of cell and tissue processing and of cryopreservation, the possible failures that obtained the highest overall risk score were errors in the administration of drugs and the request being incomplete and/or made at an inappropriate time. The largest number of possible failures were found in the activities concerning sample collection and manipulation. Twelve evaluation indicators were defined. DiscussionThis study highlights the existence of latent system failures, which may become inherent to the procedures and provoke errors, hence the importance of continuing to monitor the proposed indicators to measure results over a longer period and to evaluate the effect of the actions taken.

Preanalytical Nonconformity Management Regarding Primary Tube Mixing in Brazil.

SummaryBackgroundThe multifaceted clinical laboratory process is divided in three essential phases: the preanalytical, analytical and postanalytical phase. Problems emerging from the preanalytical phase are responsible for more than 60% of laboratory errors. This report is aimed at highlighting and discussing nonconformity (e.g., nonstandardized procedures) in primary blood tube mixing immediately after blood collection by venipuncture with evacuated tube systems.MethodsFrom January 2015 to December 2015, fifty different laboratory quality managers from Brazil were contacted to request their internal audit reports on nonconformity regarding primary blood tube mixing immediately after blood collection by venipuncture performed using evacuated tube systems.Results and ConclusionsA minority of internal audits (i.e., 4%) concluded that evacuated blood tubes were not accurately mixed after collection, whereas more than half of them reported that evacuated blood tubes were vigorously mixed immediately after collection, thus magnifying the risk of producing spurious hemolysis. Despite the vast ma jority of centers declaring that evacuated blood tubes were mixed gently and carefully, the overall number of inversions was found to be different from that recommended by the manufacturer. Since the turbulence generated by the standard vacuum pressure inside the primary evacuated tubes seems to be sufficient for providing solubilization, mixing and stabilization between additives and blood during venipuncture, avoidance of primary tube mixing probably does not introduce a major bias in tests results and may not be considered a nonconformity during audits for accreditation.

MALDI-TOF-Based Dermatophyte Identification.

MALDI-TOF MS has become increasingly popular for microorganism identification in the routine laboratory. Compared with conventional morphology-based techniques, MALDI-TOF is relatively inexpensive (per-unit identification), involves a rapid result turnaround time and yields more accurate results without the need for highly qualified staff. However, this technology has been technically difficult to implement for filamentous fungi identification. Identification of dermatophytes, a type of filamentous fungi, remains particularly challenging, partly due to the lack of clear species definition for some taxa or within some species complexes. Review of the ten studies published between 2008 and 2015 shows that the accuracy of MALDI-TOF MS-based identification varied between 13.5 and 100% for dermatophytes. This variability was partly due to inconsistencies concerning critical steps of the routine clinical laboratory process. Use of both a complete formic acid-acetonitrile protein extraction step and a manufacturer library supplemented with homemade reference spectra is essential for an accurate species identification. This technique is conversely unaffected by variations in other routine clinical laboratory conditions such as culture medium type, incubation time and type of mass spectrometry instrument. Provided that a reference spectra library is adequate for dermatophyte identification, MALDI-TOF MS identification is more economical and offers an accuracy comparable to that of DNA sequencing. The technique also represents an advantageous alternative to the protracted and labor-intensive dermatophyte identification via macroscopic and microscopic morphology in the routine clinical laboratory.

Study of continuous quality improvement for clinical laboratory processes via the platform of Hospital Group

The program of continuous quality improvement in clinical laboratory processes for complete blood count (CBC) was launched via the platform of Beijing Children's Hospital Group in order to improve the quality of pediatric clinical laboratories. Fifteen children's hospitals of Beijing Children's Hospital group were investigated using the method of Chinese adapted continuous quality improvement with PDCA (Plan-Do-Check-Action). The questionnaire survey and inter-laboratory comparison was conducted to find the existing problems, to analyze reasons, to set forth quality targets and to put them into practice. Then, targeted training was conducted to 15 children's hospitals and the second questionnaire survey, self examinations by the clinical laboratories was performed. At the same time, the Group's online internal quality control platform was established. Overall effects of the program were evaluated so that lay a foundation for the next stage of PDCA. Both quality of control system documents and CBC internal quality control scheme for all of clinical laboratories were improved through this program. In addition, standardization of performance verification was also improved, especially with the comparable verification rate of precision and internal laboratory results up to 100%. In terms of instrument calibration and mandatory diagnostic rates, only three out of the 15 hospitals (20%) failed to pass muster in 2014 from 46.67% (seven out of the 15 hospitals) in 2013. The abnormal data of intraday precision variance coefficients of the five CBC indicator parameters (WBC, RBC, Hb, Plt and Hct) of all the 15 laboratories accounted for 1.2% (2/165) in 2014, a marked decrease from 9.6% (14/145) in 2013. While the number of the hospitals using only one horizontal quality control object for daily quality control has dropped to three from five. The 15 hospitals organized a total of 263 times of training in 2014 from 101 times in 2013, up 160%. The quality improvement program for the clinical laboratories launched via the Hospital Group platform can promote the joint development of the pediatric clinical laboratory discipline of all the member hospitals with remarkable improvement results, and the experience is recommendable for further rollout.

A Trend Analysis of Quality Indicators of Patient Safety in the Clinical Laboratory Over 21 Months

Objectives To evaluate the quality indicators covering the critical steps in the pre- and postanalytical phases and to study their trends over a 21-month period in the laboratory. Methods A prospective analysis of results obtained from our clinical chemistry and haematology laboratories, which function independently, for errors in the pre- and postanalytical phases was carried out to observe the trend for all the errors after the implementation of 3 patient-safety strategies. Results A significant improvement was observed in completeness of test requisition forms (TRFs) received in the laboratory after staff training. Incidence of sample rejection decreased dramatically after the implementation of a second patient-safety activity; it dropped further after the introduction of evacuated tubes. Almost 100% improvement was observed in critical and urgent reporting. Conclusion Use of quality indicators to assess and monitor clinical-laboratory processes is an extremely valuable tool in maintaining quality control in a systematic and transparent way. * IOM : Institute of Medicine TTP : total testing process TRF : test requisition form IQC : internal quality control SOPs : standard operating procedures LIS : laboratory information system

Identification of Factors Contributing to Variability in a Blood-Based Gene Expression Test

BackgroundCorus CAD is a clinically validated test based on age, sex, and expression levels of 23 genes in whole blood that provides a score (1–40 points) proportional to the likelihood of obstructive coronary disease. Clinical laboratory process variability was examined using whole blood controls across a 24 month period: Intra-batch variability was assessed using sample replicates; inter-batch variability examined as a function of laboratory personnel, equipment, and reagent lots.Methods/ResultsTo assess intra-batch variability, five batches of 132 whole blood controls were processed; inter-batch variability was estimated using 895 whole blood control samples. ANOVA was used to examine inter-batch variability at 4 process steps: RNA extraction, cDNA synthesis, cDNA addition to assay plates, and qRT-PCR. Operator, machine, and reagent lots were assessed as variables for all stages if possible, for a total of 11 variables. Intra- and inter-batch variations were estimated to be 0.092 and 0.059 Cp units respectively (SD); total laboratory variation was estimated to be 0.11 Cp units (SD). In a regression model including all 11 laboratory variables, assay plate lot and cDNA kit lot contributed the most to variability (p = 0.045; 0.009 respectively). Overall, reagent lots for RNA extraction, cDNA synthesis, and qRT-PCR contributed the most to inter-batch variance (52.3%), followed by operators and machines (18.9% and 9.2% respectively), leaving 19.6% of the variance unexplained.ConclusionIntra-batch variability inherent to the PCR process contributed the most to the overall variability in the study while reagent lot showed the largest contribution to inter-batch variability.

Applicability and potential benefits of benchmarking in Brazilian clinical laboratory services

PurposeThe purpose of this paper is to test the applicability and benefits of benchmarking as a tool for quality analysis in Brazilian laboratory medical services.Design/methodology/approachA primary observational study is performed in eight hospital laboratories by tracking the receipt, analysis and return to participants of monitoring reports relating to several quality indicators for the years 2005 and 2006. Whenever possible, the paper applies 6σ criteria as an independent assessment of process quality.FindingsData obtained for the eight laboratories showed a monthly average (±SD) of 178,579 (±153,670) tests performed per laboratory, with 40,256 (±44,858) requisitions and 4.77 (±1.33) tests per requisition. Overall, productivity was 7.35 (±2.46) tests per man‐hour of work (MHW), increasing to 15.36 (±6.00) when considering only the analytical sector staff. An average of 1.63 (±1.14) lost hours per hundred MHW were reported (level 3.6σ), with 3.86 (±5.10) accidents at work reported (AWR) per hundred thousand MHW (level 5.5σ) and 4.22 (±2.61) redraws per thousand requisitions attended (level 4.1σ). The turn‐around‐times were 2.25 (±0.98), 3.29 (±2.12) and 8.54 (±3.25) hours for glucose level, haemogram and human immunodeficiency virus serology, respectively.Practical implicationsBenchmarking proved to be a useful and feasible tool for quality management in Brazilian clinical laboratories, particularly when associated with independent tools for evaluating the quality of laboratorial processes.Originality/valueThis is the first Brazilian study reporting that benchmarking provides useful information on the performance of different clinical laboratory processes and, therefore, could become an important tool for laboratory management.