Survey of national guidelines, education and training on phlebotomy in 28 European countries: an original report by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PA).

BACKGROUND: European questionnaire survey was conducted by the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PA) to assess how phlebotomy is performed in EFLM countries, including differences in personnel, level of education and skills, and to investigate the presence and compliance of national phlebotomy guidelines on this matter. METHODS: A questionnaire was constructed containing questions elucidating different aspects of the organization behind the phlebotomy praxis on a national basis, including questions on the staff performing phlebotomy, the education of these staff members, and the existence of and adherence to national guidelines. All 39 EFLM member countries were invited to participate. RESULTS: In total 28/39 (72%) EFLM member countries responded. Seven out of the 28 (25%) have national phlebotomy guidelines and five have implemented other guidelines. The estimated compliance with phlebotomy guidance for the laboratories in the countries that have national guidelines available is poor, regardless to whether the phlebotomy was under the laboratory control or not. Most countries were interested in EFLM guidelines and to participate in a pilot EFLM preanalytical phase external quality assessment (EQA) scheme. In the responding EFLM member countries, the majority of phlebotomy is performed by nurses and laboratory technicians. Their basic education is generally 4-5 years of high school, followed by 2-5 years of colleague or university studies. Only a third (10/28; 36%) of the participating member countries has any specific training available as a continuous educational resource. A specific training for phlebotomy is not part of the education required to become qualified in 6/28 (21%) and 9/28 (32%) of countries for nurses and laboratory technicians, respectively. In countries and professions where training is required, most require more than 5 h of training. CONCLUSIONS: Based on the results of this survey we conclude the following: 1) There is a need to assess the quality of current practices, compliance to the CLSI H3-A6 guidelines and to identify some most critical steps which occur during phlebotomy, in different healthcare settings, across Europe; 2) Existing CLSI H3-A6 phlebotomy guidelines should be adapted and used locally in all European countries which do not have their own guidelines; 3) National EFLM societies need to be engaged in basic training program development and continuous education of healthcare phlebotomy staff (implementing the certification of competence).

[Joint EFLM-COLABIOCLI recommendation for venous blood sampling]. / Recommandations communes EFLM-COLABIOCLI relatives au prélèvement sanguin veineux.

This document provides a joint recommendation for venous blood sampling of the European federation of clinical chemistry and laboratory medicine (EFLM) Working Group for preanalytical phase (WG-PRE) and Latin American working group for preanalytical phase (WG-PRE-LATAM) of the Latin America confederation of clinical biochemistry (COLABIOCLI). It offers guidance on the requirements for ensuring that blood collection is a safe and patient-centered procedure and provides practical guidance on how to successfully overcome potential barriers and obstacles to its widespread implementation. The target audience for this recommendation are healthcare staff members directly involved in blood collection. This recommendation applies to the use of a closed blood collection system and does not provide guidance for the blood collection with an open needle and syringe and catheter collections. Moreover, this document neither addresses patient consent, test ordering, sample handling and transport nor collection from children and unconscious patients. The recommended procedure is based on the best available evidence. Each step was graded using a system that scores the quality of the evidence and the strength of the recommendation. The process of grading was done at several face-to-face meetings involving the same mixture of stakeholders stated previously. The main parts of this recommendation are: 1) Pre-sampling procedures, 2) Sampling procedure, 3) Post-sampling procedures and 4) Implementation. A first draft of the recommendation was circulated to EFLM members for public consultation. WG-PRE-LATAM was also invited to comment the document. A revised version has been sent for voting on to all EFLM and COLABIOCLI members and has been officially endorsed by 33/40 EFLM and 21/21 COLABIOCLI members. We encourage professionals throughout Europe and Latin America to adopt and implement this recommendation to improve the quality of blood collection practices and increase patient and workers safety.

[Accreditation of the toxicological screening: recommendations of the SFBC-SFTA group]. / Accréditation du criblage toxicologique : recommandations du groupe SFBC-SFTA.

Toxicological screening is a specific approach to analytical toxicology that uses analytical tools such as GC-MS, LC-UV (diode array) or LC-MS. Toxicological screening allows the detection and simultaneous identification of a large number of compounds. The results may be based on the use of one or more techniques. As part of the accreditation process for medical biology examinations according to standard NF EN ISO 15189, the group from SFTA and SFBC recommends an approach to accredit toxicological screening. Indeed, the complexity of the accreditation of this analysis comes in particular from the high number of compounds that can be detected. Validation parameters are discussed in the specific context of toxicological screening by considering two distinct approaches: the simple identification of compounds, or the identification and estimation of a range of concentration related to clinical outcomes.

Computer-assisted bar-coding system significantly reduces clinical laboratory specimen identification errors in a pediatric oncology hospital.

OBJECTIVE: To assess the ability of a bar code-based electronic positive patient and specimen identification (EPPID) system to reduce identification errors in a pediatric hospital's clinical laboratory. STUDY DESIGN: An EPPID system was implemented at a pediatric oncology hospital to reduce errors in patient and laboratory specimen identification. The EPPID system included bar-code identifiers and handheld personal digital assistants supporting real-time order verification. System efficacy was measured in 3 consecutive 12-month time frames, corresponding to periods before, during, and immediately after full EPPID implementation. RESULTS: A significant reduction in the median percentage of mislabeled specimens was observed in the 3-year study period. A decline from 0.03% to 0.005% (P < .001) was observed in the 12 months after full system implementation. On the basis of the pre-intervention detected error rate, it was estimated that EPPID prevented at least 62 mislabeling events during its first year of operation. CONCLUSIONS: EPPID decreased the rate of misidentification of clinical laboratory samples. The diminution of errors observed in this study provides support for the development of national guidelines for the use of bar coding for laboratory specimens, paralleling recent recommendations for medication administration.

Quality improvements in the preanalytical phase: focus on urine specimen workflow.

Despite advances in the performance of analytic systems, there still remains a high level of variability in the total testing process. Most laboratory errors currently occur in the preanalytical phase, which is complex because it consists of numerous steps. To reduce the number of errors in the preanalytical phase and achieve targeted quality improvements, particular attention should focus on process improvement and reduction of unnecessary steps. Using the example of urine specimen collection and processing, major causes of preanalytical variability are identified, as are potential areas of process improvement that significantly impact quality of urine testing. Means of achieving them through application of various Lean techniques are also discussed.

Performance specifications and six sigma theory: Clinical chemistry and industry compared.

Analytical performance specifications are crucial in test development and quality control. Although consensus has been reached on the use of biological variation to derive these specifications, no consensus has been reached which model should be preferred. The Six Sigma concept is widely applied in industry for quality specifications of products and can well be compared with Six Sigma models in clinical chemistry. However, the models for measurement specifications differ considerably between both fields: where the sigma metric is used in clinical chemistry, in industry the Number of Distinct Categories is used instead. In this study the models in both fields are compared and discussed.

Resident training in clinical chemistry.

Practicing clinical chemists responded to an anonymous, open-ended questionnaire designed to define the state of clinical chemistry education in pathology training programs in the United States. Survey respondents identified many ideas for educational improvements and offered criticism regarding aspects of clinical chemistry education that are not working particularly well. Many of these findings are generalizable to other subspecialties of clinical pathology. It is hoped that this analysis will allow readers to compare their programs with national trends and identify new ways of improving clinical chemistry training at their institutions.

Laboratory automation: total and subtotal.

Worldwide, perhaps 2000 or more clinical laboratories have implemented some form of laboratory automation, either a modular automation system, such as for front-end processing, or a total laboratory automation system. This article provides descriptions and examples of these various types of automation. It also presents an outline of how a clinical laboratory that is contemplating automation should approach its decision and the steps it should follow to ensure a successful implementation. Finally, the role of standards in automation is reviewed.

National turnaround time survey: professional consensus standards for optimal performance and thresholds considered to compromise efficient and effective clinical management.

Background Turnaround time can be defined as the time from receipt of a sample by the laboratory to the validation of the result. The Royal College of Pathologists recommends that a number of performance indicators for turnaround time should be agreed with stakeholders. The difficulty is in arriving at a goal which has some evidence base to support it other than what may simply be currently achievable technically. This survey sought to establish a professional consensus on the goals and meaning of targets for laboratory turnaround time. Methods A questionnaire was circulated by the National Audit Committee to 173 lead consultants for biochemistry in the UK. The survey asked each participant to state their current target turnaround time for core investigations in a broad group of clinical settings. Each participant was also asked to provide a professional opinion on what turnaround time would pose an unacceptable risk to patient safety for each departmental category. A super majority (2/3) was selected as the threshold for consensus. Results The overall response rate was 58% ( n = 100) with a range of 49-72% across the individual Association for Clinical Biochemistry and Laboratory Medicine regions. The consensus optimal turnaround time for the emergency department was <1 h with >2 h considered unacceptable. The times for general practice and outpatient department were <24 h and >48 h and for Wards <4 h and >12 h, respectively. Conclusions We consider that the figures provide a useful benchmark of current opinion, but clearly more empirical standards will have to develop alongside other aspects of healthcare delivery.

Improving preanalytic processes using the principles of lean production (Toyota Production System).

The basic technologies used in preanalytic processes for chemistry tests have been mature for a long time, and improvements in preanalytic processes have lagged behind improvements in analytic and postanalytic processes. We describe our successful efforts to improve chemistry test turnaround time from a central laboratory by improving preanalytic processes, using existing resources and the principles of lean production. Our goal is to report 80% of chemistry tests in less than 1 hour and to no longer recognize a distinction between expedited and routine testing. We used principles of lean production (the Toyota Production System) to redesign preanalytic processes. The redesigned preanalytic process has fewer steps and uses 1-piece flow to move blood samples through the accessioning, centrifugation, and aliquoting processes. Median preanalytic processing time was reduced from 29 to 19 minutes, and the laboratory met the goal of reporting 80% of chemistry results in less than 1 hour for 11 consecutive months.

The Canadian Society of Clinical Chemists: highlights of its first 50 years.

This article has been written to mark the 50th anniversary of the Canadian Society of Clinical Chemists (CSCC). It is not an exhaustive history of CSCC's activities but rather a review of many of the highlights that the Society and its members have experienced since its founding in October 1956. The names of many members who made important contributions to CSCC's development (but by no means all) are mentioned in the text. The historical material is presented by the decade but with blurred boundaries, as noteworthy advances in CSCC's history have most often developed gradually over several years and the terms of office of several CSCC Councils. From a founding roster of slightly over 70 members, the membership has grown to several hundred. The two main objectives for the Society's founding were stated by one of the three Montrealers who extended the original invitation, Dr. William S. Bauld: "to raise the standards of performance, and to raise the professional standing of clinical chemists". The early reports of committees on Instrumentation, Methods and Quality Control had rapid impact on individual members' laboratory practices across the country. The struggle for recognition of clinical chemists by other health professions inside and outside the clinical laboratories has taken much longer and has consisted of a long series of incremental successes through certification by examination, training programs, continuing education and, ultimately, the formation in 1986 of the Canadian Academy of Clinical Biochemistry. The CSCC's means of intra- and inter-communication with external organizations consist of its newsletter CSCC News, its scientific journal Clinical Biochemistry (established in 1967), and its more recently created website www.cscc.ca (1997). These three mechanisms ensure exchange of information between the officers of CSCC Council and the general membership and among members as well. National and international conferences have offered the newest scientific discoveries pertinent to the profession, exhibits featuring the latest in increasingly sophisticated instrumentation and reagents, and abundant opportunity to exchange information informally with old and newly met colleagues. By their contributions to the International Federation of Clinical Chemistry and the International Union of Pure and Applied Chemistry, CSCC members continue to play important roles far beyond Canada's borders.

The role of European Federation of Clinical Chemistry and Laboratory Medicine Working Group for Preanalytical Phase in standardization and harmonization of the preanalytical phase in Europe.

Patient safety is a leading challenge in healthcare and from the laboratory perspective it is now well established that preanalytical errors are the major contributor to the overall rate of diagnostic and therapeutic errors. To address this, the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for Preanalytical Phase (EFLM WG-PRE) was established to lead in standardization and harmonization of preanalytical policies and practices at a European level. One of the key activities of the WG-PRE is the organization of the biennial EFLM-BD conference on the preanalytical phase to provide a forum for National Societies (NS) to discuss their issues. Since 2012, a year after the first Preanalytical phase conference, there has been a rapid growth in the number of NS with a working group engaged in preanalytical phase activities and there are now at least 19 countries that have one. As a result of discussions with NS at the third conference held in March 2015 five key areas were identified as requiring harmonisation. These were test ordering, sample transport and storage, patient preparation, sampling procedures and management of unsuitable specimens. The article below summarises the work that has and will be done in these areas. The goal of this initiative is to ensure the EFLM WG-PRE produces work that meets the needs of the European laboratory medicine community. Progress made in the identified areas will be updated at the next preanalytical phase conference and show that we have produced guidance that has enhanced standardisation in the preanalytical phase and improved patient safety throughout Europe.

Implementation of a successful on-call system in clinical chemistry.

Successful practice of clinical pathology depends on a wide variety of laboratory, clinical, and managerial decisions. The skills needed to make these decisions can most effectively be learned by residents and fellows in pathology using a service-oriented on-call approach. We report our experience implementing an on-call system in the clinical chemistry laboratory at the University of Louisville Hospital (Ky). We detail the guidelines used to establish this system and the elements required for its successful implementation. The system emphasizes a laboratory-initiated approach to linking laboratory results to patient care. From inception of the program during late 1990 through 1995, the number of beeper calls (including clinician contacts) steadily increased and is currently 8 to 20 per week. The on-call system is active 24 hours per day, 7 days per week, thus representing activity on all three laboratory shifts. Types of responses were separated into administrative (12%), analytical (42%), clinical (63%), quality control or quality assurance (12%), and consultation (13%) categories. We also present 6 case reports as examples demonstrating multiple elements in these categories. In 23% of the calls, clinician contact was required and achieved by the fellow or resident on call for the laboratory. The on-call reports are documented and presented informally at weekly on-call report sessions. Emphasis is placed on learning and refinement of investigative skills needed to function as an effective laboratory director. Educational emphasis for the medical staff is in establishing awareness of the presence of the laboratory as an important interactive component of patient care. In addition, we found this program to be beneficial to the hospital and to the department of pathology in fulfilling its clinical service and teaching missions. Our experience may be helpful to other institutions establishing such a program.

The EC4 quality manual model.

One of the priorities of the European Confederation of Clinical Chemistry (EC4) is the harmonisation of the clinical laboratory profession in Europe. One of the first steps is to try to harmonise the quality systems, that is, the clinical laboratory organisational structure, responsibilities, procedures, processes and resources involved in quality management. The "EC4 Essential Criteria" were published by the Working Group on Harmonisation of Quality Systems in order to facilitate the development or the update of a quality system in a clinical laboratory, and to encourage international bodies to produce specific Standards for the clinical laboratory. Furthermore, the EC4 Working Group has produced a Quality Manual Model, which includes a sample of quality policy documents and some operational directions for an imaginary laboratory. This Quality Manual Model was prepared following the "EC4 Essential Criteria." Its purpose is that any quality system developed following the Manual could be accredited or certified against any Standard. The EC4 Quality Manual Model will be available, free of charge, to clinical laboratory professionals.

Standards for the medical laboratory--harmonization and subsidiarity.

An International Standard, ISO 15189, specifically for 'Quality management in the medical laboratory' for use by accrediting 'bodies that recognize the competence of medical laboratories,' is expected to be published shortly. The origins, content and limitations of the new standard are discussed and the diversity of current arrangements for accreditation is reviewed. A new International Standard is an important step towards harmonization of laboratory practice but an accreditation system is more than its standards and a harmonized approach to the treatment of noncompliances found at inspection is important. Experience gained in writing national standards can improve the approach to the drafting and improvement of International Standards. Recognition of the principle of subsidiarity aids rather than hinders progress to harmonization and empowers the 'fourth element' (the laboratories to be accredited) to be a part of the accreditation process.

Accreditation of medical laboratories. Some reflections from the Nordic Horizon.

Accreditation has been a successful approach to improved quality management in laboratories and applied to a wide variety of medical laboratories. After the initial enthusiastic phase, in which quality improvement is significant, the endurance is threatened by an increasing bureaucracy of the process. A productive balance between the accreditation bodies and the profession needs to be sought. New standards have been suggested by ISO and the profession needs to take the initiative to assure that a global standard specially adopted to the requirements of medical laboratories becomes recognised and used. The new concept of uncertainty may become an important tool to further improve and describe the performance of laboratories by allowing inclusion of pre- and post-analytical sources of uncertainty as well as bias.

IVD industry role for quality and accreditation in medical laboratories.

Manufacturers of in vitro diagnostic (IVD) medical devices and laboratory management have become integral partners in building and improving the quality of laboratory services. There is an increasing awareness that quality is inherent in the design of any reagent or analytical system. In vitro diagnostic medical devices should provide patients, users and third parties with a high level of health protection. Therefore, both manufacturers and users must work in partnership for continual improvement. For manufacturers, standards such as ISO 9000 already exist to guide applications of quality practices. In the field of laboratory medicine, the availability of a specific, universal standard (ISO/DIS 15189) for quality management in medical laboratories will represent a great opportunity for harmonising medical laboratories at an international level. In addition, accreditation of medical laboratories according to the proposed ISO 15189 standard can help develop the relationships between laboratories, and the biological follow-up of travelling patients. Manufacturers are able to help laboratory management to reach a high level of quality, not only by providing high value products, but also on the basis of their own experience of ISO 9000 certification.

External Quality Assessment Schemes: need for recognised requirements.

Programs for Accreditation of clinical laboratories consider participation in External Quality Assessment Schemes (EQAS) a key element in the evaluation of testing procedures and improving them. One of the main functions of EQAS is to assess whether laboratories perform tests competently. It is therefore of utmost importance for laboratories to participate in EQAS that are in line with formally recognised requirements. Specific proposals have been made on how to design and execute EQAS by International Working Groups, but there seems to be no consensus on the best strategies to use and quality specifications to set out. The Clinical Pathology Accreditation (CPA) Program for EQA Scheme Accreditation (CPA-EQA) is the only program in Europe to provide a formal recognition of the quality of EQAS activities. The present paper reports on the experience of the Centre of Biomedical Research which is following an accreditation process for their own schemes in line with the CPA-EQA program and a proposal to set requirements that Italian schemes must follow to be recognised as valid and effective.