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Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement (v.5, #9)
Adam Uldall was awarded the J Westgard Award at the conference on "Quality [R]evolution in Clinical Laboratories" in Antwerp
by Paul De Bièvre (pp. 357-357).
The 5th European Conference on Quality in Medical Laboratories, Antwerp, Belgium, 11–12 October, 1999
by J. C. Libeer; H. M. J. Goldschmidt (pp. 358-359).
Total quality management in hematology by S. S. Ehrmeyer; Ronald H. Laessig (pp. 360-362).
Healthcare is changing and clinical laboratory testing must change with it. In no discipline is this change more profound than in hematology. The principles of total quality management (TQM) including continuous quality improvement, reengineering and strategic planning can facilitate these changes. In the past, hematology has often been exlcuded from these processes due to its many manual procedures and the degree of expertise and skill needed to perform the testing. As automated technology continues to evolve, hematology testing, like other testing, will become integrated into the core, clinical laboratory. We suggest TQM can, and should, guide the way.
Keywords: Key words Hematology; Total quality management; Continuous quality improvement; Quality control; Quality assurance; Chematology
The quest for comparability: Calibration 2000 by Rob T. P. Jansen (pp. 363-366).
Most efforts in quality control have been focussed on the reduction of intralaboratory variation and the assessment of interlaboratory variation. Over the last few years, the importance of bias in interlaboratory variation and intralaboratory shifts has become clear. Small shifts can sometimes have a large impact on the number of treated patients, particularly in assays where cut off values are used. For example in cholesterol, HDL-cholesterol, HbA1c and TSH assays. There is an obvious need for adequate calibration material. However, the process of development of international primary reference materials and reference methods takes time, and even if reference materials exist and are used by in vitro diagnostics manufacturers, there still remains significant and clinically relevant interlaboratory variance and intralaboratory shifts, as is seen, e.g. in protein chemistry. The harmonization of inter laboratory and intralaboratory results needs an impulse from professional organizations to convince individual laboratories of the importance and significance of bias. This applies to all subdisciplines of laboratory medicine. On the occasion of the 25th anniversary of the Foundation for External Quality Assessment (SKZL), a large interdisciplinary harmonization project called Calibration 2000 was launched in The Netherlands The strategy and first results are reported in this paper. The project aims at harmonization of laboratory data of several disciplines, using secondary calibration materials, leading to common reference ranges throughout The Netherlands.
Keywords: Key words Quality assessment; Bias; Harmonization; Calibration; Laboratory medicine
Hematological health-related intervals estimated using an indirect method in order to satisfy the accreditation standards by R. M. Dorizzi; Michele Schinella; Antonella Pupillo; Luca Endrizzi (pp. 367-370).
The estimation of reference limits represents quite a taxing task for laboratories which frequently adopt the limits suggested by manufacturers or those reported in the literature. This practice does not meet the requirements of accreditation programs (i.e. Essential Criteria, Clinical Pathology Accreditation) that require laboratories to produce or check all their reference intervals. We collected 15 244 hematological results from females aged 0–99 years obtained by the Rovereto Hospital Laboratory and calculated the reference intervals, or to be more precise the health-related intervals, using an indirect method (based on all the inpatient and outpatient results). All the measurements were carried out using an automatic Coulter STK S analyzer, and the results were transferred to Verona by e-mail. The results for hemoglobin were: <1 year (n=154)=90–171 g/l; 2–8 years (n=619)=104–136 g/l; 9–14 years (n=322)=118–143 g/l; 15–44 years (n=6329)=106–144 g/l; 45–75 years (n=4893)=107–148 g/l; 75–99 years (n=2927)=90–153 g/l. The results appear different from the results currently used by Rovereto Hospital (120–160 g/l) but comparable to those reported in the literature with the exception of the subjects under 1 year and over 75 years, probably due to the excess of "diseased" subjects in these classes. The indirect method allows even small laboratories to produce or check their reference intervals for all age groups, increasing the clinical effectiveness of laboratory results and satisfying the accreditation standards.
Keywords: Key words Hematological quantities; Health-related intervals; Reference limits; Accreditation program
Internal user inquiries as a useful tool for adjustment of the quality system and for quality improvement by H. Islin; Steen Thystrup (pp. 371-373).
Who could be better than the staff themselves to point out inappropriate and ineffective elements in a quality system? A dialogue between the supplier and the customer for clarification of the customers' requirements and possible quality problems is often part of a quality management system. Of no less importance is a dialogue with the staff who "live" with the quality system in the everyday work environment, handling procedures, keeping records, and controlling documents, etc. For this reason a simple internal user inquiry was conducted. The anonymous inquiry form considered areas which effect daily work, and posed questions which, we had reasons to believe, could be tender points among staff. The result was a very positive feedback on the questions, and several advantages and disadvantages were brought forward. Our experience after 2 years with ISO 9001 certification is that internal inquiries are just as important as the dialogue with customers in maintaining an appropriate and effective quality system. Furthermore, such inquiries focus on the quality system and involve the staff in adjustments, tailoring the system and in quality improvements.
Keywords: Key words ISO 9001; Employee involvement; Quality development; Quality improvement; Quality system appraisal
Telematics applications in a laboratory cluster by Hans Küffer (pp. 374-376).
The laboratories of six hospitals in the Canton of Wallis in Switzerland have been connected to one central laboratory, using the same database, the same software applications for the laboratory, pathology and pharmacy, and the same office and administration software. Some instruments in "Point of Care" sites are online for result transmission and for telemaintenance. The physicians may order drugs, material for sampling, analyses for specified patients and may consult knowledge bases, the patient data base, results and reports in different formats (ASCII, HTML, PDF, JPG, GIF, ...) using browsers like Netscape or MS-Explorer. To guarantee privacy, the access is restricted and protected by user-name, password and firewall. This report describes conditions for a successful introduction and usage of quality management through laboratory telematics.
Keywords: Key words Telematics; Telemaintenance; Standardization of services; Internet applications
The practical advantages of hospital quality systems such as NIAZ/PACE by F. Linnebank (pp. 377-380).
The Netherlands Institute for Accreditation of Hospitals (NIAZ) was established at the end of 1998. It was founded by the PACE foundation, the Society of University Hospitals, the Netherlands Association of General Hospitals and the Society of Medical Specialists in the Netherlands. Since then in the Netherlands 19 pilot accreditations have been performed based upon 35 NIAZ-PACE standards for hospital departments and functions, and the overall standard 'quality system'. The aims and methods of the accreditation system were inspired by examples from the other side of the Atlantic, especially from Canada. The characteristics are: voluntary-based, self-evaluation, peer-review and aiming at continuous improvement of quality of care.
Keywords: Key words Dutch hospital accreditation standards; Hospital accreditation; TQM; Quality systems
Quality assurance in immunogenetics and histocompatibility: experience with EFI Accreditation by G. Mertens; Maria Gielis; Denise De Smet; Gert Van Cleynenbreugel (pp. 381-382).
The European Federation for Immunogenetics (EFI) has its own standards for histocompatibility testing. Compared with EN 45001 and ISO Standards, EFI Standards are more detailed, actually stating "what to do" in the laboratory. The decision of Eurotransplant that all its organ transplantation programmes must be EFI-accredited by the year 2000, illustrates the importance of the these standards. It took us 11 months to prepare the EFI questionnaire, describing the main features of our laboratory and how they complied with EFI Standards. After approval of this file, inspection was performed by a team of two peers who routinely worked in an EFI-accredited tissue typing laboratory. The pre-analytical, analytical and post-analytical phases were inspected during a one day visit. Furthermore, a checklist was reviewed against the laboratory's documentation system. Within 1 month of reception of the inspection report, we were expected to send a reply listing the corrective actions taken. Upon acknowledgement of the latter, EFI Accreditation was granted, for 1 year. We feel that detailed standards, specifically designed for a certain type of laboratory, offer many advantages.
Keywords: Key words Accreditation; EFI; Eurotransplant; Immunogenetics; Histocompatibility standardization
Reference intervals of serum folate and vitamin B12 developed from data of healthy subjects by Tijen Tanyalcin; Diler Aslan; Yusuf Kurtulmus; Nalan Gökalp; Kamil Kumanlioğlu (pp. 383-387).
In this study the reference intervals for folate and vitamin B12 were estimated according to the National Committee for Clinical Laboratory Standards Approved Guideline C28-A and International Federation of Clinical Chemistry recommendations. The study included 155 women and 124 men between ages 18–40. The health status was confirmed by history, physical examination and a questionnaire. The central 95% reference intervals of serum folate and vitamin B12 for women, determined non-parametrically, were found to be 3.9–18.1 ng/ml and 101–666.7 pg/ml, respectively. The reference values of serum folate and vitamin B12 for men were also found to be 2,5–17.6 ng/ml and 100–699.57 pg/ml, respectively. We did not observe subclass differences between females and males.
Keywords: Key words Folate; Vitamin B12; Reference intervals; Sex related differences; Practical guideline use
CITAC Position Paper: Traceability in chemical measurement
by Ioannis Papadakis; Wolfhard Wegscheider (pp. 388-389).
Proficiency testing schemes for therapeutics and toxicology by David W. Holt (pp. 389-391).
This report addresses the proposition: current proficiency testing (PT) schemes for therapeutics and toxicology can easily engender complacency. The proposition was based on the premise that there are substantial between-laboratory differences and objectives in the supply of services for the measurement of drugs, as a result of which it is difficult to design PT schemes which adequately cover the requirements of all laboratories. Thus, acceptable performance in a PT scheme may lead participants to consider that they have tested their procedures more rigorously than is the case. Four areas, validity of the PT scheme, PT material, frequency of testing and acceptance criteria are examined.
Keywords: Key words Proficiency testing; Matrix effects; Therapeutic drug monitoring; Toxicology acceptance criteria
Keeping the spotlight on quality from a distance by Doug Hirst; A. St John (pp. 391-393).
Maintaining the quality of testing in remote locations can be demanding of laboratory resources in terms of daily visits to instruments and providing support outside of normal working hours. Recently technology and software solutions have appeared to reduce this burden for laboratory scientists dramatically. The AVL Auto QC unit, in conjunction with OMNILink software, allow laboratory staff to perform many quality control and maintenance procedures on instruments in wards and medical units from a PC in the central laboratory. Assessment of this technology and software in the Special Baby Care Unit at Bradford Royal Infirmary has demonstrated many benefits including reduction in ward visits, better support out of hours, regular quality control checks, and improved analytical quality.
Keywords: Key words Quality control; Critical care testing; Decentralized testing; Quality outcomes; Quality assessment
ISO/IEC 17025 : 1999 – The new Standard for Laboratories
by Peter J. H. A. M. van de Leemput (pp. 394-397).
Global trends in quality specifications: a report from the Stockholm Conference by Anders Kallner (pp. 397-398).
In Stockholm a conference entitled: "Strategies to Set Global Quality Specifications in Laboratory Medicine" was held in April 1999. The primary aim in organizing the Conference was to provide a vehicle for reaching consensus on global quality specifications in laboratory medicine. This objective was achieved and a lively constructive debate, after the presentations were complete, led to agreement on the principles laid down in the Consensus Statement. The International Federation of Clinical Chemistry (IFCC), the International Union of Pure and Applied Chemistry (IUPAC) and the World Health Organization (WHO) kindly sponsored the Conference but it must be noted that the Consensus Statement reflects the views of the presenters and registrants who participated in the Conference and does not necessarily represent those of the sponsoring bodies. This paper reports on the standardization efforts so far, the Stockholm Consensus Conference, the ISO uncertainty concept and the consensus reality. A hierarchy of quality specifications in laboratory medicine was defined and agreed on.
Keywords: Key words Quality specifications; Harmonization quality concepts; Uncertainty in measurement