Improvement of Clinical Laboratory Services through Quality

2013 ◽  
Vol 2 (2) ◽  
pp. 38-46 ◽  
Author(s):  
Antonia Mourtzikou ◽  
Marilena Stamouli ◽  
Elena Athanasiadi
Keyword(s):  
Quality Control ◽  
Health Care Providers ◽  
Clinical Laboratory ◽  
Internal Quality ◽  
Care Providers ◽  
Improvement Program ◽  
Laboratory Performance ◽  
Laboratory Services ◽  
Poor Individual ◽  
Eqa Schemes

Health care providers need test results that are relevant, accurate, and reliable for patient care. The term “quality control” is used to describe the set of procedures used to check that the results of laboratory tests are reliable for the intended clinical use. A laboratory might produce results that are considered unsatisfactory. While the cause for this might be immediately apparent, the identification of the underlying problem is neither always straightforward, nor easy because many factors can affect result quality. Internal quality control (IQC) and external quality assessment (EQA) are two distinct but complementary components of a laboratory quality improvement program. IQC ensures day-to-day laboratory consistency. EQA permits the identification of poor individual laboratory performance, as well as the detection of reagents, instruments and methods that produce unreliable or misleading results, by means of a retrospective analysis of data obtained by participating laboratories. Continuous participation in EQA schemes has been linked to improved laboratory performance.

Guidelines for the Reporting of Nongynecologic Cytopathology Specimens

2009 ◽  
Vol 133 (11) ◽  
pp. 1743-1756
Author(s):  
Barbara A. Crothers ◽  
William D. Tench ◽  
Mary R. Schwartz ◽  
Joel S. Bentz ◽  
Ann T. Moriarty ◽  
...  
Keyword(s):  
Health Care ◽  
Health Care Providers ◽  
Ad Hoc ◽  
Clinical Laboratory ◽  
Needle Aspiration ◽  
Health Care Team ◽  
Major Elements ◽  
Pathology Report ◽  
Care Providers ◽  
Healthcare Organizations

Abstract Context.—Gynecologic cytology terminology and report formatting have been nationally standardized since the implementation of The Bethesda System of 1988, but standard reporting for nongynecologic cytology has never been formally addressed on the same scale. Objectives.—To promote patient safety through uniform reporting in nongynecologic cytology (including fine-needle aspiration cytology) and to improve communication between laboratories and health care providers. Data Sources.—Sources include the College of American Pathologists Cytopathology Resource Committee; the College of American Pathologists Council on Scientific Affairs Ad Hoc Committee on Pathology Report Standardization; the College of American Pathologists Laboratory Accreditation Program inspection checklists; the Joint Commission for Accreditation of Healthcare Organizations; and the Clinical Laboratory Improvement Amendments of 1988. Conclusions.—We describe the major elements of quality nongynecologic cytology reporting and discuss areas of controversy in cytology reporting. Standardized nongynecologic specimen reporting will expand the concept of common report elements already widely implemented in gynecologic cytology reporting. The intent is to improve communication with the health care team while remaining in compliance with federal mandates and accreditation guidelines.

Physician Satisfaction With Clinical Laboratory Services: A College of American Pathologists Q-Probes Study of 138 Institutions

2009 ◽  
Vol 133 (1) ◽  
pp. 38-43
Author(s):  
Bruce A. Jones ◽  
Leonas G. Bekeris ◽  
Raouf E. Nakhleh ◽  
Molly K. Walsh ◽  
Paul N. Valenstein
Keyword(s):  
Quality Improvement ◽  
Clinical Laboratory ◽  
Turnaround Time ◽  
Physician Satisfaction ◽  
Reliability Of Results ◽  
Improvement Program ◽  
Valuable Component ◽  
Laboratory Services ◽  
Survey Results ◽  
High Level

Abstract Context.—Monitoring customer satisfaction is a valuable component of a laboratory quality improvement program. Objective.—To survey the level of physician satisfaction with hospital clinical laboratory services. Design.—Participating institutions provided demographic and practice information and survey results of physician satisfaction with defined aspects of clinical laboratory services, rated on a scale of 1 (poor) to 5 (excellent). Results.—One hundred thirty-eight institutions participated in this study and submitted a total of 4329 physician surveys. The overall satisfaction score for all institutions ranged from 2.9 to 5.0. The median overall score for all participants was 4.1 (10th percentile, 3.6; 90th percentile, 4.5). Physicians were most satisfied with the quality/reliability of results and staff courtesy, with median values of excellent or good ratings of 89.9%. Of the 5 service categories that received the lowest percentage values of excellent/good ratings (combined scores of 4 and 5), 4 were related to turnaround time for inpatient stat, outpatient stat, routine, and esoteric tests. Surveys from half of the participating laboratories reported that 96% to 100% of physicians would recommend the laboratory to other physicians. The category most frequently selected as the most important category of laboratory services was quality/reliability of results (31.7%). Conclusions.—There continues to be a high level of physician satisfaction and loyalty with clinical laboratory services. Test turnaround times are persistent categories of dissatisfaction and present opportunities for improvement.

scholarly journals Application of Sigma Metrics for Evaluating the Analytical Performance of Thyroid Profile and Cortisol in Clinical Biochemistry Laboratory

2020 ◽  
Author(s):  
Smita Natvarbhai Vasava ◽  
Roshni Gokaldas Sadaria
Keyword(s):  
Quality Control ◽  
Six Sigma ◽  
Clinical Laboratory ◽  
Clinical Biochemistry ◽  
Poor Performance ◽  
Analytical Performance ◽  
Internal Quality ◽  
Six Sigma Methodology ◽  
Clinical Biochemistry Laboratory ◽  
Thyroid Profile

Introduction: Now-a-days quality is the key aspect of clinical laboratory services. The six sigma metrics is an important quality measurement method for evaluating the performance of the clinical laboratory. Aim: To assess the analytical performance of clinical biochemistry laboratory by utilising thyroid profile and cortisol parameters from Internal Quality Control (IQC) data and to calculate sigma values. Materials and Methods: Study was conducted at Clinical Biochemistry Laboratory, Dhiraj General Hospital, Piparia, Gujarat, India. Retrospectively, IQC data of thyroid profile and cortisol were utilised for six subsequent months (July to December 2019). Coefficient of Variation (CV%) and bias were calculated from IQC data, from that the sigma values were calculated. The sigma values <3, >3 and >6 were indicated by poor performance procedure, good performance and world class performance, respectively. Results: The sigma values were estimated by calculating mean of six months. The mean sigma value of Thyroid Stimulating Hormone (TSH) and Cortisol were >3 for six months which indicated the good performance. However, sigma value of Triiodothyronine (T3), Tetraiodothyronine (T4) were found to be <3 which indicated poor performance. Conclusion: Six sigma methodology applications for thyroid profile and cortisol was evaluated, it was generally found as good. While T3 and T4 parameters showed low sigma values which requires detailed root cause analysis of analytical process. With the help of six sigma methodology, in clinical biochemistry laboratories, an appropriate Quality Control (QC) programming should be done for each parameter. To maintain six sigma levels is challenging to quality management personnel of laboratory, but it will be helpful to improve quality level in the clinical laboratories.

Internal Quality Control of PCR-based Genotyping Methods in Research Studies and Patient Diagnostics

2002 ◽  
Vol 87 (05) ◽  
pp. 812-816 ◽  
Author(s):  
Jørgen Gram ◽  
Jørgen Jespersen ◽  
Moniek de Maat ◽  
Else-Marie Bladbjerg
Keyword(s):  
Quality Control ◽  
Clinical Laboratory ◽  
Dna Amplification ◽  
Restriction Enzymes ◽  
Control Programme ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Reagent Blank ◽  
Thrombosis Research ◽  
Control Programmes

SummaryGenetic analyses are increasingly integrated in the clinical laboratory, and internal quality control programmes are needed. We have focused on quality control aspects of selected polymorphism analyses used in thrombosis research. DNA was isolated from EDTA-blood (n = 500) by ammonium acetate precipitation and analysed for 18 polymorphisms by polymerase chain reaction (PCR), i. e. restriction fragment length polymorphisms, allele specific amplification, or amplification of insertion/deletion fragments. We evaluated the following aspects in the analytical procedures: sample handling and DNA-isolation (pre-analytical factors), DNA-amplification, digestion with restriction enzymes, electrophoresis (analytical factors), result reading and entry into a database (post-analytical factors). Furthermore, we evaluated a procedure for result confirmation. Isolated DNA was of good quality (42 µ.g/ml blood, A260/A280 ratio >1.75, negative DNAsis tests), and the reagent blank was contaminated in <1% of the results. Occasionally, results were re-analysed because of positive reagent blanks (<1%) or because of problems with the controls (< 5%). On confirmation, we observed 4 genotyping discrepancies. Control of data handling revealed 0.1% reading mistakes and 0.5% entry mistakes. Based on our experiences we propose an internal quality control programme for widely used PCR-based haemostasis polymorphism analyses.

scholarly journals A UK Survey of Laboratory-Based Gastrointestinal Investigations

1998 ◽  
Vol 35 (4) ◽  
pp. 492-503 ◽  
Author(s):  
A Duncan ◽  
P G Hill
Keyword(s):  
Quality Control ◽  
Analytical Methods ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Gastrointestinal Function ◽  
Reference Ranges ◽  
Hospital Laboratory ◽  
Function Tests ◽  
Laboratory Services

A survey of hospital laboratory services has demonstrated marked deficiencies in the performance of gastrointestinal function tests. The repertoire of gastrointestinal investigations available varies widely between laboratories and, in general, analyses are performed infrequently. Most laboratories do not perform internal quality control, and inter-laboratory reproducibility of some analytes is very poor. A wide variety of protocols and reference ranges are in use, many of which are unevaluated. Some analytical methods and protocols in current use are outdated, with published improvements not being applied.

scholarly journals Appraisal of the domestic kit «MICMICRO » for antimicrobial susceptibility testing by serial microdilution method

2020 ◽  
pp. 231-236
Author(s):  
Anna A. Samoilova ◽  
L.A. Kraeva ◽  
I.V. Likhachev ◽  
E.V. Rogacheva ◽  
V.N. Verbov ◽  
...  
Keyword(s):  
Escherichia Coli ◽  
Quality Control ◽  
Susceptibility Testing ◽  
New Technologies ◽  
Clinical Laboratory ◽  
Clinical Isolates ◽  
Internal Quality ◽  
Diagnostic Efficiency ◽  
Microdilution Method ◽  
Reference Strains

Objective. To assess efficiency of the “MIC-MICRO” kit developed in the Department of New Technologies of the Saint-Petersburg Pasteur Institute, on reference strains and clinical bacterial isolates. Materials and Methods. In order to assess the “MIC-MICRO” kit, several options of its execution were used, including different groups of antibiotics: aztreonam, amikacin, gentamicin, colistin, meropenem, nitrofurantoin, chloramphenicol, cefotaxime, ceftriaxone, ciprofloxacin, erythromycin. In order to determine the range of antibiotic values, the EUCAST-2020 database was used. The quality control of adsorbed antibiotics was carried out using reference strains: Escherichia coli ATCC 25922, Staphylococcus aureus ATCC 29213 and Escherichia coli NCTC 13846 (colistin-resistant). Acceptable and target ranges of MIC values for control strains are evaluated according to “Regular and extended internal quality control for determining MIC and disk diffusion according to EUCAST recommendations” (v10.0). A total of 28 clinical isolates of K. pneumoniae obtained from patients with nosocomial infections in St. Petersburg hospitals in 2018–2019 was used in the study. The coordination of test results was obtained in accordance with GOST R ISO 20776-1-2010. Susceptibility testing results were interpreted in accordance with EUCAST recommendations (v10.0). Results. The MIC values in relation to the reference strains obtained using the “MIC-MICRO” kit were determined in the range of recommended values of the EUCAST-2020 standard. The results obtained in relation to clinical isolates of K. pneumoniae showed that the sensitivity categories determined using the developed kit and the serial microdilution method were the same for all the studied strains. The percentage of colistin-resistant isolates (MIC > 2 mg/ml) in the serial microdilution method and determined using the “MIC-MICRO” kit was 35.7%. The percentage of susceptible strains was also similar for two types of methods (64.3%). Conclusions. Colistin susceptibility testing of K. pneumoniae strains using the “MIC-MICRO” diagnostic kit and the reference serial microdilution method in a tablet, showed comparable results. Diagnostic efficiency, ease to use and simple interpretation of results make it possible to use the developed “MIC-MICRO” kit in clinical laboratory practice.

Assuring the quality of interpretative comments in clinical chemistry

2016 ◽  
Vol 54 (12) ◽  
Author(s):  
Samuel Vasikaran ◽  
Kenneth Sikaris ◽  
Eric Kilpatrick ◽  
Jane French ◽  
Tony Badrick ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Continuing Professional Development ◽  
Laboratory Staff ◽  
Laboratory Services ◽  
Method Of Assessment ◽  
The Impact ◽  
Eqa Schemes ◽  
Interpretative Comments

AbstractThe provision of interpretative advice on laboratory results is a post-analytic activity and an integral part of clinical laboratory services. It is valued by healthcare workers and has the potential to prevent or reduce errors and improve patient outcomes. It is important to ensure that interpretative comments provided by laboratory personnel are of high quality: comments should be patient-focused and answer the implicit or explicit question raised by the requesting clinician. Comment providers need to be adequately trained and qualified and be able to demonstrate their proficiency to provide advice on laboratory reports. External quality assessment (EQA) schemes can play a part in assessing and demonstrating the competence of such laboratory staff and have an important role in their education and continuing professional development. A standard structure is proposed for EQA schemes for interpretative comments in clinical chemistry, which addresses the scope and method of assessment including nomenclature and marking scales. There is a need for evidence that participation in an EQA program for interpretative commenting facilitates improved quality of comments. It is proposed that standardizing goals and methods of assessment as well as nomenclature and marking scales may help accumulate evidence to demonstrate the impact of participation in EQA for interpretative commenting on patient outcome.

scholarly journals Bringing the clinical laboratory into the strategy to advance diagnostic excellence

Diagnosis ◽  
2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Ira M. Lubin ◽  
J. Rex Astles ◽  
Shahram Shahangian ◽  
Bereneice Madison ◽  
Ritchard Parry ◽  
...  
Keyword(s):  
Quality Management ◽  
Health Care Providers ◽  
Clinical Laboratory ◽  
Laboratory Data ◽  
Diagnostic Errors ◽  
Care Quality ◽  
Diagnostic Process ◽  
Management Approach ◽  
Care Providers ◽  
Medical Diagnoses

Abstract Objectives Clinical laboratory testing provides essential data for making medical diagnoses. Generating accurate and timely test results clearly communicated to the treating clinician, and ultimately the patient, is a critical component that supports diagnostic excellence. On the other hand, failure to achieve this can lead to diagnostic errors that manifest in missed, delayed and wrong diagnoses. Content Innovations that support diagnostic excellence address: 1) test utilization, 2) leveraging clinical and laboratory data, 3) promoting the use of credible information resources, 4) enhancing communication among laboratory professionals, health care providers and the patient, and 5) advancing the use of diagnostic management teams. Integrating evidence-based laboratory and patient-care quality management approaches may provide a strategy to support diagnostic excellence. Professional societies, government agencies, and healthcare systems are actively engaged in efforts to advance diagnostic excellence. Leveraging clinical laboratory capabilities within a healthcare system can measurably improve the diagnostic process and reduce diagnostic errors. Summary An expanded quality management approach that builds on existing processes and measures can promote diagnostic excellence and provide a pathway to transition innovative concepts to practice. Outlook There are increasing opportunities for clinical laboratory professionals and organizations to be part of a strategy to improve diagnoses.

scholarly journals Implementing Self Sustained Quality Control Procedures in a Clinical Laboratory

2013 ◽  
Vol 52 (189) ◽  
pp. 233-237 ◽  
Author(s):  
Roshan Khatri ◽  
Sanjay KC ◽  
Prabodh Shrestha ◽  
J N Sinha
Keyword(s):  
Quality Control ◽  
Clinical Laboratory ◽  
Reliability And Validity ◽  
Disease Diagnosis ◽  
Mitigation Measures ◽  
Internal Quality ◽  
Control Procedure ◽  
Random Errors ◽  
Control Rules ◽  
Control Serum

Introduction: Quality control is an essential component in every clinical laboratory which maintains the excellence of laboratory standards, supplementing to proper disease diagnosis, patient care and resulting in overall strengthening of health care system. Numerous quality control schemes are available, with combinations of procedures, most of which are tedious, time consuming and can be “too technical” whereas commercially available quality control materials can be expensive especially for laboratories in developing nations like Nepal. Here, we present a procedure performed at our centre with self prepared control serum and use of simple statistical tools for quality assurance. Methods: The pooled serum was prepared as per guidelines for preparation of stabilized liquid quality control serum from human sera. Internal Quality Assessment was performed on this sample, on a daily basis which included measurement of 12 routine biochemical parameters. The results were plotted on Levey-Jennings charts and analysed with quality control rules, for a period of one month. Results: The mean levels of biochemical analytes in self prepared control serum were within normal physiological range. This serum was evaluated every day along with patients’ samples. The results obtained were plotted on control charts and analysed using common quality control rules to identify possible systematic and random errors. Immediate mitigation measures were taken and the dispatch of erroneous reports was avoided. Conclusions: In this study we try to highlight on a simple internal quality control procedure which can be performed by laboratories, with minimum technology, expenditure, and expertise and improve reliability and validity of the test reports. Keywords: Levey-Jennings charts; pooled sera; quality control; Westgard Rule.

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