scholarly journals Challenges of Laboratory Medicine: European Answers

2011 ◽  
Vol 30 (4) ◽  
pp. 273-278 ◽  
Author(s):  
Irena Korita ◽  
Victor Blaton
Keyword(s):  
Strategic Alliances ◽  
Business Models ◽  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Biomedical Sciences ◽  
Clinical Laboratories ◽  
Laboratory Services ◽  
Enhance Efficiency

Challenges of Laboratory Medicine: European Answers Medical laboratories play a vital role in modern healthcare, and qualified specialists in Clinical Chemistry and Laboratory Medicine are essential for the provision of high-quality preanalytical, analytical and consultative services. Laboratory medicine has undergone major transformations during the last decade. Ongoing technological developments have considerably improved the productivity of clinical laboratories. Information on laboratory services is globally available, and clinical laboratories worldwide face international competition and there is a huge pressure to reduce costs. To be prepared for the future, clinical laboratories should enhance efficiency and reduce the cost increases by forming alliances and networks, consolidating, integrating or outsourcing, and more importantly create additional value by providing knowledge services related to in vitro diagnostics. Therefore, business models that increase efficiency such as horizontal and vertical integration are proposed, based on collaborative networks for the delivery of clinical laboratory services. Laboratories should cooperate, consolidate and form strategic alliances to enhance efficiency and reduce costs. There is a growing conflict between the science and the art of clinical practice and on the role of the biomedical sciences in medical practice. We have a dehumanizing effect on medical care. Disease is defined at the level of sick molecules and cells and curative medicine is being replaced by the preventive care of the disease. Undoubtedly all those questions will raise considerable problems and challenges for the medical educators.

scholarly journals Laboratory Medicine: Challenges and Opportunities

2007 ◽  
Vol 53 (10) ◽  
pp. 1730-1733 ◽  
Author(s):  
Xavier Bossuyt ◽  
Kurt Verweire ◽  
Norbert Blanckaert
Keyword(s):  
Laboratory Medicine ◽  
In Vitro Diagnostics ◽  
Clinical Laboratories ◽  
The Future ◽  
Challenges And Opportunities ◽  
Enhance Efficiency ◽  
Additional Value ◽  
Knowledge Services

Abstract Technologic innovations have substantially improved the productivity of clinical laboratories, but the services provided by clinical laboratories are increasingly becoming commoditized. We reflect on how current developments may affect the future of laboratory medicine and how to deal with these changes. We argue that to be prepared for the future, clinical laboratories should enhance efficiency and reduce costs by forming alliances and networks; consolidating, integrating, or outsourcing; and more importantly, create additional value by providing knowledge services related to in vitro diagnostics.

Properties and Units in the Clinical Laboratory Sciences. Part XIX. Properties and Units for Transfusion Medicine and Immunohematology (IUPAC Technical Report)

2003 ◽  
Vol 75 (10) ◽  
pp. 1477-1600 ◽  
Author(s):  
K. Varming ◽  
U. Forsum ◽  
Ivan Bruunshuus ◽  
H. Olesen
Keyword(s):  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Laboratory Data ◽  
Working Party ◽  
Laboratory Medicine ◽  
General Introduction ◽  
International Union ◽  
Ongoing Effort ◽  
Technical Report ◽  
Clinical Laboratory Sciences

This document is part of an ongoing effort to standardize transmission of laboratory data across cultural and linguistic domains, without attempting to standardize the routine language used by clinicians and laboratory practitioners. It comprises a general introduction and an alphabetic list of properties. The list is based on the syntax for properties recommended by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the International Union of Pure and Applied Chemistry (IUPAC). The nomenclature is primarily from the Working Party on Terminology of the International Society of Blood Transfusion (ISBT).

scholarly journals Laboratory Automation: Trajectory, Technology, and Tactics

2000 ◽  
Vol 46 (5) ◽  
pp. 764-771 ◽  
Author(s):  
Rodney S Markin ◽  
Scott A Whalen
Keyword(s):  
Process Control ◽  
Clinical Laboratory ◽  
Healthcare Delivery ◽  
Computer Integrated Manufacturing ◽  
Automation System ◽  
Laboratory Automation ◽  
In Vitro Diagnostics ◽  
Laboratory Services ◽  
Automation Technology

Abstract Laboratory automation is in its infancy, following a path parallel to the development of laboratory information systems in the late 1970s and early 1980s. Changes on the horizon in healthcare and clinical laboratory service that affect the delivery of laboratory results include the increasing age of the population in North America, the implementation of the Balanced Budget Act (1997), and the creation of disease management companies. Major technology drivers include outcomes optimization and phenotypically targeted drugs. Constant cost pressures in the clinical laboratory have forced diagnostic manufacturers into less than optimal profitability states. Laboratory automation can be a tool for the improvement of laboratory services and may decrease costs. The key to improvement of laboratory services is implementation of the correct automation technology. The design of this technology should be driven by required functionality. Automation design issues should be centered on the understanding of the laboratory and its relationship to healthcare delivery and the business and operational processes in the clinical laboratory. Automation design philosophy has evolved from a hardware-based approach to a software-based approach. Process control software to support repeat testing, reflex testing, and transportation management, and overall computer-integrated manufacturing approaches to laboratory automation implementation are rapidly expanding areas. It is clear that hardware and software are functionally interdependent and that the interface between the laboratory automation system and the laboratory information system is a key component. The cost-effectiveness of automation solutions suggested by vendors, however, has been difficult to evaluate because the number of automation installations are few and the precision with which operational data have been collected to determine payback is suboptimal. The trend in automation has moved from total laboratory automation to a modular approach, from a hardware-driven system to process control, from a one-of-a-kind novelty toward a standardized product, and from an in vitro diagnostics novelty to a marketing tool. Multiple vendors are present in the marketplace, many of whom are in vitro diagnostics manufacturers providing an automation solution coupled with their instruments, whereas others are focused automation companies. Automation technology continues to advance, acceptance continues to climb, and payback and cost justification methods are developing.

Role of laboratory medicine in collaborative healthcare

2018 ◽  
Vol 0 (0) ◽  
Author(s):  
Ian D. Watson ◽  
Patricia Wilkie ◽  
Amir Hannan ◽  
Graham H. Beastall
Keyword(s):  
Clinical Laboratory ◽  
Point Of Care ◽  
Healthcare Delivery ◽  
Continuing Professional Development ◽  
Laboratory Medicine ◽  
Sources Of Information ◽  
Patient Centered ◽  
Laboratory Service ◽  
Laboratory Services ◽  
Centered Care

Abstract Healthcare delivery and responsibility is changing. Patient-centered care is gaining international acceptance with the patient taking greater responsibility for his/her health and sharing decision making for the diagnosis and management of illness. Laboratory medicine must embrace this change and work in a tripartite collaboration with patients and with the clinicians who use clinical laboratory services. Improved communication is the key to participation, including the provision of educational information and support. Knowledge management should be targeted to each stakeholder group. As part of collaborative healthcare clinical laboratory service provision needs to be more flexible and available, with implications for managers who oversee the structure and governance of the service. Increased use of managed point of care testing will be essential. The curriculum content of laboratory medicine training programs will require trainees to undertake practice-based learning that facilitates interaction with patients, clinicians and managers. Continuing professional development for specialists in laboratory medicine should also embrace new sources of information and opportunities for collaborative healthcare.

First WHO/IFCC International Reference Reagent for Lipoprotein(a) for Immunoassay – Lp(a) SRM 2B

2004 ◽  
Vol 42 (6) ◽  
Author(s):  
Francesco Dati ◽  
Jillian R. Tate ◽  
Santica M. Marcovina ◽  
Armin Steinmetz
Keyword(s):  
Disease Risk ◽  
Clinical Chemistry ◽  
Cardiovascular Disease Risk ◽  
Metrological Traceability ◽  
Reference Method ◽  
Laboratory Medicine ◽  
Expert Committee ◽  
International Reference ◽  
Lipoprotein A

AbstractLipoprotein(a) is an important predictor of cardiovascular disease risk. The lack of internationally accepted standardization has impeded the broad application of this lipoprotein in laboratory medicine. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), through its Working Group on Lipoprotein(a) and together with research institutions and several diagnostic companies, have succeeded in developing an international reference material that is intended for the transfer of a lipoprotein(a) concentration to manufacturers' master calibrators. IFCC SRM 2B has recently been accepted by the WHO Expert Committee on Biological Standardization as the ‘First WHO/IFCC International Reference Reagent for Lipoprotein(a) for Immunoassay’. The assigned unitage of 0.1071 nanomoles of lipoprotein(a) per vial is traceable to the consensus reference method for lipoprotein( a) and will enable conformity by diagnostic companies to the European Union's Directive on In vitro Diagnostic Medical Devices for the metrological traceability of calibrator materials.

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 Regulation of Laboratory-Developed Tests

2019 ◽  
Vol 152 (2) ◽  
pp. 122-131 ◽  
Author(s):  
Jonathan R Genzen
Keyword(s):  
Clinical Laboratory ◽  
Leading Edge ◽  
Regulatory Reform ◽  
The United States ◽  
In Vitro Diagnostics ◽  
Regulatory Oversight ◽  
Clinical Laboratories ◽  
Legislative Proposals ◽  
Key Issues

Abstract Objectives To provide a clinical laboratory perspective on the Verifying Accurate Leading-edge IVCT Development Act (VALID) discussion draft. This potential legislative effort, if enacted, would overhaul the regulatory oversight of in vitro diagnostics (IVDs) in the United States and create a single system for regulation of conventional IVDs and laboratory-developed tests (LDTs). Methods A concise literature-based review of LDT regulation is presented followed by a discussion of key concerns pertinent to clinical laboratories that should be considered in future IVD regulatory reform efforts. Results Key issues identified include the importance of fostering innovation, preserving patient safety, protecting the practice of laboratory medicine, and minimizing undue regulatory burden. Clinical laboratories are not equivalent to manufacturing facilities and would therefore encounter challenges in implementing device-centric regulatory oversight models. Conclusions It is imperative that a clinical laboratory perspective on LDTs is understood and incorporated prior to advancement of future legislative proposals.

National surveys on 15 quality indicators for the total testing process in clinical laboratories of China from 2015 to 2017

2018 ◽  
Vol 57 (2) ◽  
pp. 195-203 ◽  
Author(s):  
Min Duan ◽  
Xudong Ma ◽  
Jing Fan ◽  
Yanhong Guo ◽  
Wei Wang ◽  
...  
Keyword(s):  
Quality Indicators ◽  
Clinical Chemistry ◽  
Turnaround Time ◽  
Laboratory Medicine ◽  
General Information ◽  
Critical Values ◽  
Medical Quality ◽  
Clinical Laboratories ◽  
Analytical Phase ◽  
Total Testing Process

Abstract Background As effective quality management tools, quality indicators (QIs) are widely used in laboratory medicine. This study aimed to analyze the results of QIs, identify errors and provide quality specifications (QSs) based on the state-of-the-art. Methods Clinical laboratories all over China participated in the QIs survey organized by the National Health Commission of People’ Republic of China from 2015 to 2017. Most of these QIs were selected from a common model of QIs (MQI) established by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). All participants were asked to submit general information and original QIs data through a medical quality control data collection system. The results of QIs were reported in percentages and sigma, except turnaround time (TAT) which was measured in minutes. The 25th, 50th and 75th percentiles were, respectively, calculated as three levels of QSs, which were defined starting from the model proposed during the 1st Strategic Conference of the EFLM on “Defining analytical performance 15 years after the Stockholm Conference on Quality Specification in Laboratory Medicine”. Results A total of 76 clinical laboratories from 25 provinces in China continuously participated in this survey and submitted complete data for all QIs from 2015 to 2017. In general, the performance of all reported QIs have improved or at least kept stable over time. Defect percentages of blood culture contamination were the largest in the pre-analytical phase. Intra-laboratory TAT was always larger than pre-examination TAT. Percentage of tests covered by inter-laboratory comparison was relatively low than others in the intra-analytical phase. The performances of critical values notification and timely critical values notification were the best with 6.0σ. The median sigma level of incorrect laboratory reports varied from 5.5σ to 5.7σ. Conclusions QSs of QIs provide useful guidance for laboratories to improve testing quality. Laboratories should take continuous quality improvement measures in all phases of total testing process to ensure safe and effective tests.

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