scholarly journals Management of postanalytical processes in the clinical laboratory according to ISO 15189:2012 Standard requirements: considerations on the review, reporting and release of results

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Mᵃ Liboria López Yeste ◽  
Silvia Izquierdo Álvarez ◽  
Antonia R. Pons Mas ◽  
Luisa Álvarez Domínguez ◽  
Fernando Marqués García ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Test Results ◽  
Correct Interpretation ◽  
Laboratory Management ◽  
Iso 15189 ◽  
Effective Implementation ◽  
Clinical Laboratories ◽  
Global Trend ◽  
Laboratory Results ◽  
Critical Results

Abstract The objective of this paper is to share some considerations about the management of postanalytical processes in relation to the review, reporting and release of test results in accordance with UNE-EN ISO 15189:2013 Standard requirements. The scope of this paper includes postanalytical activities and the personnel involved (laboratory management and staff). We describe the criteria and information required to review and validate analytical results and ensure that clear reports are sent to requesters. These criteria also guarantee that results are transcribed in a reliable way and that all necessary information is provided for the correct interpretation of results. Likewise, the requirements for the correct release of laboratory results are described, with special emphasis on the release of alarming or critical results. In some European countries, clinical laboratories are required to hold partial or full ISO 15189 accreditation, which is a global trend. Therefore, understanding ISO 15189 requirements is imperative for a progressive and more effective implementation of the Standard.

Document Control Practices in 120 Clinical Laboratories

2009 ◽  
Vol 133 (6) ◽  
pp. 942-949
Author(s):  
Paul N. Valenstein ◽  
Ana K. Stankovic ◽  
Rhona J. Souers ◽  
Frank Schneider ◽  
Elizabeth A. Wagar
Keyword(s):  
Patient Outcomes ◽  
Clinical Laboratory ◽  
Standard Setting ◽  
Clinical Laboratory Improvement Amendment ◽  
Clinical Laboratories ◽  
Policies And Procedures ◽  
Laboratory Results ◽  
Control Failures

Abstract Context.—A variety of document control practices are required of clinical laboratories by US regulation, laboratory accreditors, and standard-setting organizations. Objective.—To determine how faithfully document control is being implemented in practice and whether particular approaches to document control result in better levels of compliance. Design.—Contemporaneous, structured audit of 8814 documents used in 120 laboratories for conformance with 6 generally accepted document control requirements: available, authorized, current, reviewed by management, reviewed by staff, and archived. Results.—Of the 8814 documents, 3113 (35%) fulfilled all 6 document control requirements. The requirement fulfilled most frequently was availability of the document at all shifts and locations (8564 documents; 97%). Only 4407 (50%) of documents fulfilled Clinical Laboratory Improvement Amendment requirements for being properly archived after updating or discontinuation. Policies and procedures were more likely to fulfill document control requirements than forms and work aids. Documents tended to be better controlled in some laboratory sections (eg, transfusion service) than in others (eg, microbiology and client services). We could not identify document control practices significantly associated with higher compliance rates. Conclusions.—Most laboratories are not meeting regulatory and accreditation requirements related to control of documents. It is not clear whether control failures have any impact on the quality of laboratory results or patient outcomes.

Herbal Remedies: Effects on Clinical Laboratory Tests

2006 ◽  
Vol 130 (4) ◽  
pp. 521-528 ◽  
Author(s):  
Amitava Dasgupta ◽  
David W. Bernard
Keyword(s):  
Chinese Medicine ◽  
Laboratory Test ◽  
Alternative Medicine ◽  
Clinical Laboratory ◽  
Herbal Remedies ◽  
Test Results ◽  
Abnormal Laboratory ◽  
St John's Wort ◽  
Laboratory Test Results ◽  
Laboratory Results

AbstractContext.—Complementary and alternative medicine (herbal medicines) can affect laboratory test results by several mechanisms.Objective.—In this review, published reports on effects of herbal remedies on abnormal laboratory test results are summarized and commented on.Data Sources.—All published reports between 1980 and 2005 with the key words herbal remedies or alternative medicine and clinical laboratory test, clinical chemistry test, or drug-herb interaction were searched through Medline. The authors' own publications were also included. Important results were then synthesized.Data Synthesis.—Falsely elevated or falsely lowered digoxin levels may be encountered in a patient taking digoxin and the Chinese medicine Chan Su or Dan Shen, owing to direct interference of a component of Chinese medicine with the antibody used in an immunoassay. St John's wort, a popular herbal antidepressant, increases clearance of many drugs, and abnormally low cyclosporine, digoxin, theophylline, or protease inhibitor concentrations may be observed in a patient taking any of these drugs in combination with St John's wort. Abnormal laboratory results may also be encountered owing to altered pathophysiology. Kava-kava, chaparral, and germander cause liver toxicity, and elevated alanine aminotransferase, aspartate aminotransferase, and bilirubin concentrations may be observed in a healthy individual taking such herbal products. An herbal product may be contaminated with a Western drug, and an unexpected drug level (such as phenytoin in a patient who never took phenytoin but took a Chinese herb) may confuse the laboratory staff and the clinician.Conclusions.—Use of alternative medicines may significantly alter laboratory results, and communication among pathologists, clinical laboratory scientists, and physicians providing care to the patient is important in interpreting these results.

scholarly journals Verification of reference intervals in routine clinical laboratories: practical challenges and recommendations

2018 ◽  
Vol 0 (0) ◽  
Author(s):  
Yesim Ozarda ◽  
Victoria Higgins ◽  
Khosrow Adeli
Keyword(s):  
Clinical Laboratory ◽  
Local Population ◽  
Age Groups ◽  
External Source ◽  
Reference Intervals ◽  
Laboratory Method ◽  
Test Results ◽  
Multicenter Studies ◽  
Clinical Laboratories ◽  
Laboratory Test Results

Abstract Reference intervals (RIs) are fundamental tools used by healthcare and laboratory professionals to interpret patient laboratory test results, ideally enabling differentiation of healthy and unhealthy individuals. Under optimal conditions, a laboratory should perform its own RI study to establish RIs specific for its method and local population. However, the process of developing RIs is often beyond the capabilities of an individual laboratory due to the complex, expensive and time-consuming process to develop them. Therefore, a laboratory can alternatively verify RIs established by an external source. Common RIs can be established by large, multicenter studies and can subsequently be received by local laboratories using various verification procedures. The standard approach to verify RIs recommended by the Clinical Laboratory Standards Institute (CLSI) EP28-A3c guideline for routine clinical laboratories is to collect and analyze a minimum of 20 samples from healthy subjects from the local population. Alternatively, “data mining” techniques using large amounts of patient test results can be used to verify RIs, considering both the laboratory method and local population. Although procedures for verifying RIs in the literature and guidelines are clear in theory, gaps remain for the implementation of these procedures in routine clinical laboratories. Pediatric and geriatric age-groups also continue to pose additional challenges in respect of acquiring and verifying RIs. In this article, we review the current guidelines/approaches and challenges to RI verification and provide a practical guide for routine implementation in clinical laboratories.

scholarly journals LabRS: A Rosetta stone for retrospective standardization of clinical laboratory test results

2017 ◽  
Vol 25 (2) ◽  
pp. 121-126 ◽  
Author(s):  
Ronald George Hauser ◽  
Douglas B Quine ◽  
Alex Ryder
Keyword(s):  
Laboratory Tests ◽  
Standardized Test ◽  
Clinical Laboratory ◽  
Secondary Data ◽  
The United States ◽  
Test Results ◽  
Original Result ◽  
Clinical Laboratories ◽  
Laboratory Test Results ◽  
Standardization Process

Abstract Objective Clinical laboratories in the United States do not have an explicit result standard to report the 7 billion laboratory tests results they produce each year. The absence of standardized test results creates inefficiencies and ambiguities for secondary data users. We developed and tested a tool to standardize the results of laboratory tests in a large, multicenter clinical data warehouse. Methods Laboratory records, each of which consisted of a laboratory result and a test identifier, from 27 diverse facilities were captured from 2000 through 2015. Each record underwent a standardization process to convert the original result into a format amenable to secondary data analysis. The standardization process included the correction of typos, normalization of categorical results, separation of inequalities from numbers, and conversion of numbers represented by words (eg, “million”) to numerals. Quality control included expert review. Results We obtained 1.266 × 109 laboratory records and standardized 1.252 × 109 records (98.9%). Of the unique unstandardized records (78.887 × 103), most appeared <5 times (96%, eg, typos), did not have a test identifier (47%), or belonged to an esoteric test with <100 results (2%). Overall, these 3 reasons accounted for nearly all unstandardized results (98%). Conclusion Current results suggest that the tool is both scalable and generalizable among diverse clinical laboratories. Based on observed trends, the tool will require ongoing maintenance to stay current with new tests and result formats. Future work to develop and implement an explicit standard for test results would reduce the need to retrospectively standardize test results.

scholarly journals Workflow Optimization in a Clinical Laboratory using Lean management principles in the pre-analytical phase

2020 ◽  
Author(s):  
Pablo Letelier ◽  
Neftalí Guzmán ◽  
Gustavo Medina ◽  
Luis Calcumil ◽  
Pamela Huencho ◽  
...  
Keyword(s):  
User Satisfaction ◽  
Emergency Services ◽  
Clinical Laboratory ◽  
Clinical Results ◽  
Test Results ◽  
Lean Management ◽  
Workflow Optimization ◽  
Delivery Times ◽  
Clinical Laboratories ◽  
Analytical Phase

BACKGROUND: The application of the Lean methodology in clinical laboratories can improve workflow and user satisfaction through the efficient delivery of analytical results. The purpose of this study was to optimise delivery times of the test results at a clinical laboratory, using Lean management principles in the pre-analytical phase. METHODS: A prospective study with a quasi- experimental design was implemented. Staff functions were restructured and sample flows were modified. Delivery times of clinical results (glucose and haematocrit) from the Medicine and Adult Emergency services for years 2017 and 2018 were compared. RESULTS: A reduction (p < 0.05) in turnaround times in the delivery of glucose test results at the adult emergency service was observed (84 to 73 min, 13%, pre and post). In addition, there was a non-significant reduction in the turnaround times for glucose (Medicine) and haematocrit in both services. In the analytical and post-analytical phase (not intervened), an increase in turnaround times was observed in some cases. CONCLUSIONS: Other studies have indicated that the application of the Lean methodology in clinical laboratories improves workflow, increasing effectiveness and efficiency. This study showed an improvement in the delivery time of test results (glucose – Emergency), giving rise to a culture of cooperation and continuous improvement. It would, however, be essential to address the management model integrating the analytical and post-analytical phases.

scholarly journals Improved RT-PCR SARS-Cov2 results interpretation by indirect determination of cut-off cycle threshold value

2020 ◽  
Author(s):  
Khelil Mohamed Mokhtar
Keyword(s):  
Real Time ◽  
Clinical Laboratory ◽  
Threshold Value ◽  
Mixed Data ◽  
Rt Pcr ◽  
Data Set ◽  
Iso 15189 ◽  
Indirect Determination ◽  
Clinical Laboratories

ABSTRACTClinical laboratories of the developing world are overwhelmed with RT-PCR SARS-Cov2 testing demands. It is of paramount importance that each clinical laboratory use an appropriate cut-off value in the interpretation of SARS-Cov2 real-time RT–PCR results, which is specific to their laboratory performances as ISO 15189 recommendations stipulate. We applied an indirect statistical method to a large mixed data set of Ct values (ORF1ab and N) to estimate cut-off Ct value (∼32 cycles).we conclude that the use of indirect statistical approaches to estimate cut-off value in the interpretation of SARS-Cov2 real-time RT–PCR results may improve differential diagnosis of COVID-19 cases with low risk of infectivity, and may help to better estimates of the burden of COVID-19 disease.

scholarly journals The roadmap for harmonization: status of the International Consortium for Harmonization of Clinical Laboratory Results

2018 ◽  
Vol 56 (10) ◽  
pp. 1667-1672 ◽  
Author(s):  
Gary L. Myers ◽  
W. Greg Miller
Keyword(s):  
Clinical Laboratory ◽  
Technical Committee ◽  
Laboratory Measurement ◽  
Test Results ◽  
International Consortium ◽  
Information Portal ◽  
Resource Center ◽  
Regulatory Processes ◽  
Laboratory Test Results ◽  
Laboratory Results

Abstract The International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR) was established to fulfill recommendations identified by an international conference convened to review the available infrastructure and challenges in achieving harmonization of results among different measurement procedures. The specific objectives of the ICHCLR are to: prioritize measurands by medical importance, coordinate the work of different organizations, and stimulate development of technical and regulatory processes to achieve harmonization. Central to these objectives is the website “www.harmonization.net” developed by the ICHCLR as an information portal designed to provide a resource center for global activities to harmonize and standardize results from clinical laboratory measurement procedures. Priorities based on medical impact are provided for measurands for which harmonization is needed or work to implement harmonization is incomplete or inactive. By making information available regarding harmonization activities in progress or planned, coordination of work to harmonize laboratory measurement procedures will minimize duplication of effort and optimize the use of limited resources. A toolbox of technical procedures developed by ICHCLR to be considered when developing a process to achieve harmonization for a measurand is presented. The ICHCLR initiated a proposal to ISO Technical Committee 212 for a harmonization protocol as the basis for calibration traceability when there are no other higher order reference system components available. The ICHCLR offers a unique service to prioritize measurands in need of harmonization and to provide a centralized approach to organize global efforts to achieve harmonization of clinical laboratory test results.

Assessing Clinical Laboratory Quality: A College of American Pathologists Q-Probes Study of Prothrombin Time INR Structures, Processes, and Outcomes in 98 Laboratories

2015 ◽  
Vol 139 (9) ◽  
pp. 1108-1114 ◽  
Author(s):  
Peter J. Howanitz ◽  
Theresa P. Darcy ◽  
Frederick A. Meier ◽  
Christine P. Bashleben
Keyword(s):  
Adverse Drug Events ◽  
Clinical Laboratory ◽  
International Normalized Ratio ◽  
The United States ◽  
Time Frame ◽  
Critical Value ◽  
Clinical Laboratories ◽  
Policies And Procedures ◽  
Emergency Department Patients ◽  
Critical Results

Context The anticoagulant warfarin has been identified as the second most frequent drug responsible for serious, disabling, and fatal adverse drug events in the United States, and its effect on blood coagulation is monitored by the laboratory test called international normalized ratio (INR). Objective To determine the presence of INR policies and procedures, INR practices, and completeness and timeliness of reporting critical INR results in participants' clinical laboratories. Design Participants reviewed their INR policies and procedure requirements, identified their practices by using a questionnaire, and studied completeness of documentation and timeliness of reporting critical value INR results for outpatients and emergency department patients. Results In 98 participating institutions, the 5 required policies and procedures were in place in 93% to 99% of clinical laboratories. Fifteen options for the allowable variations among duplicate results from different analyzers, 12 different timeliness goals for reporting critical values, and 18 unique critical value limits were used by participants. All required documentation elements were present in 94.8% of 192 reviewed INR validation reports. Critical value INR results were reported within the time frame established by the laboratory for 93.4% of 2604 results, but 1.0% of results were not reported. Although the median laboratories successfully communicated all critical results within their established time frames and had all the required validation elements based in their 2 most recent INR calculations, those participants at the lowest 10th percentile were successful in 80.0% and 85.7% of these requirements, respectively. Conclusions Significant opportunities exist for adherence to INR procedural requirements and for practice patterns and timeliness goals for INR critical results' reporting.

scholarly journals Role and Responsibilities of Laboratory Medicine Specialists in the Verification of Metrological Traceability of in Vitro Medical Diagnostics / Uloga I Odgovornosti Specijalista Laboratorijske Medicine U Verifikaciji Metrološke Sledljivosti In Vitro Medicinske Dijagnostike

2015 ◽  
Vol 34 (3) ◽  
pp. 282-287 ◽  
Author(s):  
Federica Braga ◽  
Ilenia Infusino ◽  
Mauro Panteghini
Keyword(s):  
Quality Control ◽  
Measurement Uncertainty ◽  
Clinical Laboratory ◽  
Metrological Traceability ◽  
Uncertainty Budget ◽  
Medical Diagnostics ◽  
Internal Quality ◽  
Clinical Laboratories ◽  
Laboratory Results

Summary To be accurate and equivalent, laboratory results should be traceable to higher-order references. Furthermore, their quality should fulfill acceptable measurement uncertainty as defined to fit the intended clinical use. With this aim, in vitro diagnostics (IVD) manufacturers should define a calibration hierarchy to assign traceable values to their system calibrators and to fulfill during this process uncertainty limits for calibrators, which should represent a proportion of the uncertainty budget allowed for clinical laboratory results. It is therefore important that, on one hand, the laboratory profession clearly defines the clinically acceptable uncertainty for relevant tests and, on the other hand, endusers may know and verify how manufacturers have implemented the traceability of their calibrators and estimated the corresponding uncertainty. Important tools for IVD traceability surveillance are quality control programmes through the daily verification by clinical laboratories that control materials of analytical systems are in the manufacturer’s declared validation range [Internal Quality Control (IQC) component I] and the organization of Exter nal Quality Assessment Schemes meeting metrological criteria. In a separate way, clinical laboratories should also monitor the reliability of employed commercial systems through the IQC component II, devoted to estimation of the measurement uncertainty due to random effects, which includes analytical system imprecision together with individual laboratory performance in terms of variability.

Accreditation of Medical Laboratories

2021 ◽  
pp. 600-616
Author(s):  
Donovan McGrowder ◽  
Dwayne Tucker ◽  
Fabian G. Miller ◽  
Melisa Anderson ◽  
Kurt Antonio Vaz ◽  
...  
Keyword(s):  
Quality Management System ◽  
Clinical Laboratory ◽  
National Laboratory ◽  
Sub Saharan Africa ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Clinical Laboratories ◽  
Resource Limited ◽  
Sub Saharan ◽  
Formal Recognition

Quality test results generated by medical laboratories across the globe are critical for patient diagnosis and treatment. In addition, this is an area of healthcare that requires standardization. Accreditation is the formal recognition by an authoritative body noting that the clinical laboratory has an established quality management system and is competent to carry out specific tasks related to testing. The Strengthening Laboratory Management Toward Accreditation (SLMTA) program was established to strengthen national laboratory systems and to drive improvements that are immediate and measurable in developing countries, particularly those in Sub-Saharan Africa. This review seeks to look at opportunities that can be garnered by accredited medical laboratories and challenges in seeking accreditation during the implementation and operational states of the criteria of ISO 15189:2012. It also examines the progress toward clinical laboratories becoming accredited due to the enactment of the SLMTA in resource-limited settings.

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