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PubMedDate not supplied

Good Automated Laboratory Practices and other standards: validation of computer systems in the PC environment.

In summary, the validation of purchased software and add-on programs requires careful examination of the situation to determine the most effective and logical methods. A standard validation methodology that is used for larger systems would be difficult and possibly dangerous to employ for a PC system because of the significant differences between the environments. It should be noted, however, that there are almost daily changes in the computer software industry. A number of potential solutions have emerged over the past few years that can be applied to reduce the concerns caused by the apparently insufficient controls in the PC environment. For example, currently available technologies would permit multiple PC users to access a secure central application or repository of data and prevent them from making changes to a validated system or database. A properly designed system could enable these distributed users to use the data to perform their required functions, while maintaining a validated state.

Clinical Laboratory Information Systems↗
PubMed1993

[Reporting and evaluation and a blood alcohol laboratory--automated by using a new databank system].

For the processing and evaluation of a large number of data obtained in the course of blood alcohol determination the use of computerized systems is essential. By applying the software Skylight a data management program was developed under Windows. After entering the case data (name of the person involved, type of offence, time of accident and of blood sampling etc.) and BAC-values the evaluation of the data is automatically performed, e.g. calculation of the mean value, BACs at the time of event (minimum and maximum value). The user is guided by screen menus, which facilitate the entry of data. Reports are created by using predesigned formats retrieved from a report file. The data base system is installed on a local network. Access is permitted by password only to guarantee optimal security of the data.

Accidents, Traffic↗
PubMed2005

[Automation of the immunohematology laboratory].

Automation finds a particularly justified application in the field of immunohematology in which any human failure can have dramatic consequences for the patients. The purposes of automation, indissociable from computerization, were reminded by the French regulatory: to decrease the risks of human error linked to each step of the tests performed; to guarantee a reliable traceability of all the elements having contributed to the test process; to manage all the alarms of dysfunction of the system. The main devices available today permit automation of a part of the pre-analytical phase and of all the steps of the analytical phase by the realization in routine of ABO-RH1 grouping, phenotyping, of irregular antibody screening and of compatibility testing. They use the reaction of agglutination either in micro-plates or in filtration. One distinguishes two types of materials: full automates managing all the steps from the sample positioning on the carrier down to the final result without any handling of the samples (Autovue, Galileo, ID gel station, Qwalys, Tango, Techno) and the semi-automates, which require intervention of an operator for the phases of centrifugation, stirring and incubation (Mitis 2, Hemos, Rosys, Swing) the reading being automated for all. All include the possibility of a connection to the central data processing system . If some devices allow the choice of reagents, others can only work with the reagents supplied by the manufacturer. In all the cases, optimization of the automated systems implies a specific training of the staff and the strict compliance with the standard operating procedures by each individual.

Automation↗
PubMed2004

Postlicensure surveillance for pneumococcal invasive disease after use of heptavalent pneumococcal conjugate vaccine in Northern California Kaiser Permanente.

OBJECTIVE: To assess the direct and indirect effects of the introduction of routine use of pneumococcal conjugate vaccine in infants and toddlers at risk for invasive disease caused by vaccine serotypes and nonvaccine serotypes in vaccinated children and unvaccinated children of the same age. Secondary objectives included determination of the risk of pneumococcal infections in unvaccinated older children and adults in the same population and the impact of vaccine introduction on patterns of antimicrobial resistance. METHODS: Northern California Kaiser Permanente provides integrated comprehensive care to 3.1 million people and has an annual birth cohort of 38,000 infants. Microbiology services use a regional laboratory. Automated laboratory results, immunization records as well as diagnoses for inpatient and outpatient utilization are available from clinical data bases. Beginning in April 2000, the heptavalent pneumococcal conjugate (PNCV7) vaccine was introduced into routine use in the Northern California Kaiser Permanente population. Cases of invasive pneumococcal disease were identified from the automated hospital diagnosis as well as laboratory databases for all individuals, vaccinees and nonvaccinees, inpatient and outpatient. For the purpose of these analyses, pneumococcal invasive disease was defined as a positive culture from a normally sterile site. RESULTS: As of March 2003, 157,471 children had received 1 dose or more of PNCV7, but only 24% of those <2 years of age received all 4 doses as a result of shortages of vaccine. During the last year of observation, no cases of vaccine serotype disease were seen in children <1 year of age compared with an incidence ranging between 51.5 and 98.2 cases per 100,000 person-years (16-34 cases per year) in the years before vaccine introduction. Similar reductions were seen in children <5 years of age. There was no evidence of any concomitant increase in pneumococcal disease caused by nonvaccine serotypes. High level resistance of pneumococci to penicillin fell from a peak of 15% in 2000 to 5% in the first half of 2003. Similar trends were seen for other antibiotics. CONCLUSION: The PNCV7 vaccine is highly effective in reducing the burden of pneumococcal disease in children <5 years of age, and there is evidence of a herd effect as well as a decrease in the antibiotic resistant in strains causing disease. For invasive disease, there is no current evidence of serotype replacement.

Adolescent↗
PubMed2000

Stand-alone automated solutions can enhance laboratory operations.

Clinical laboratory automation has developed over the past decade as one means of consolidating testing, reducing costs, and improving the effectiveness of laboratory testing. Most of the developments have been aimed at core clinical laboratory operations, and have primarily addressed preanalytical and analytical processing of traditional specimens arriving in blood collection or similar aliquot tubes. Much less attention has been given to specialized applications such as processing specimens for urine toxicology, and only recently have vendors attacked the problems associated with sorting and maintaining the laboratory's inventory of specimens. This report highlights selected developments in these areas, describes one approach to cost-effective custom platform development, and discusses the advantages and pitfalls to solving problems with laboratory automation.

Autoanalysis↗
PubMed1993

The development of a strategy for the implementation of automation in a bioanalytical laboratory.

Laboratory automation is equipment, instrumentation, software and techniques that are classified into four groups: instrument automation; communications; data to information conversion; and information management. This new definition is necessary to understand the role that automation can play in achieving the aims and objectives of a laboratory within its organization. To undertake automation projects effectively, a laboratory automation strategy is outlined which requires an intimate knowledge of an organization and the target environment to implement individual automation projects.

Automation↗
PubMed2000

Developing an automation concept that is right for your laboratory.

BACKGROUND: Trends in laboratory automation and critical project principles and design concepts are presented. APPROACH: MDS AutoLab technology development and automation projects were reviewed. Successful methods and approaches were extracted. ISSUES: Continued pressure on the laboratory to reduce costs and increase productivity has catalyzed dramatic development in laboratory automation. Today, laboratories can choose from a wide range of options. The most effective choices are not always the most obvious and will not be the same for all laboratories. Laboratory automation projects are highly complex and must be planned and managed across clinical, technical, operational, financial, and human dimensions. CONCLUSIONS: Success requires excellent communications, an understanding of the risks and barriers, and a dedicated team supported by strong champions throughout the organization. The automation project team will need to use a variety of skills and techniques to evaluate and reengineer processes to identify the highest value targets for automation.

Automation↗
PubMedDate not supplied

Virtual automation.

Total laboratory automation (TLA) can be substituted in mid-size laboratories by a computer sample workflow control (virtual automation). Such a solution has been implemented in our laboratory using PSM, software developed in cooperation with Roche Diagnostics (Barcelona, Spain), to this purpose. This software is connected to the online analyzers and to the laboratory information system and is able to control and direct the samples working as an intermediate station. The only difference with TLA is the replacement of transport belts by personnel of the laboratory. The implementation of this virtual automation system has allowed us the achievement of the main advantages of TLA: workload increase (64%) with reduction in the cost per test (43%), significant reduction in the number of biochemistry primary tubes (from 8 to 2), less aliquoting (from 600 to 100 samples/day), automation of functional testing, drastic reduction of preanalytical errors (from 11.7 to 0.4% of the tubes) and better total response time for both inpatients (from up to 48 hours to up to 4 hours) and outpatients (from up to 10 days to up to 48 hours). As an additional advantage, virtual automation could be implemented without hardware investment and significant headcount reduction (15% in our lab).

Autoanalysis↗
PubMed1989

Prothrombin times and clottable fibrinogen determination on an automated coagulation laboratory (ACL-810).

Our laboratory evaluated an Automated Coagulation Laboratory (ACL-810) by Instrumentation Laboratory. Prothrombin times and fibrinogen levels from the ACL-810 were compared to results from a Fibrometer and another automated coagulation instrument - either the Coag-A-Mate (prothrombin times) or the Multistat III centrifugal analyzer (fibrinogen). The performance of different thromboplastins on the ACL-810 was also evaluated. Correlation studies revealed excellent performance characteristics and precisions for both the prothrombin time and fibrinogen not only with different instruments, but also with different thromboplastins on the ACL-810. Overall, we found the instrument to be quick, efficient, and easy to operate.

Autoanalysis↗
PubMed1989

[Automated instruments for clinical laboratory--its past and future].

Since the invention of the Autoanalyzer (flow system) by Skeggs in 1953 and Swedish invention of the AGA-Autochemist (discrete system) remarkable developments have been made in the field of clinical laboratory examinations. The Autoanalyzer was improved, from mono-channel to multi-channel, using various methods besides colorimetry, and with the aid of computers, it is now being applied to hematology and immunochemistry as well as chemistry. Although the AGA-Autochemist was something like a chemical factory at the beginning, various instruments using discrete system have been produced according to the refinement of the basic mechanisms of AGA-Autochemist. It is now used in other fields and has contributed considerably to clinical laboratory examinations. This article reviews the development of these instruments at intervals of five years, as reported or reviewed at the scientific meetings of the Japan Society for Clinical Laboratory Automation, and articles of the Journal of the Society. The evaluation of merits and demerits of clinical automation is omitted due to limitation of space.

Autoanalysis↗
PubMed2000

[Modularization by the open standard. (II)].

In recent years, accompanied by the marvelous development and spread of Laboratory Automation System(LAS), the NCCLS is now proposing five international standards for laboratory automation. We have based our laboratory on these "NCCLS standards of laboratory automation", we take these standards ahead first, and we now propose an open standard called "Open LA 21", to establish more detailed standard replacing the NCCLS laboratory automation standards.

Automation↗
PubMed1995

An automated hematology laboratory with computer-controlled robotics.

A highly automated hematology laboratory environment is described that has conveyance systems to move bar-coded specimens from one station ("workcell") to another, robotic handling devices to load and unload hematology analyzers, and a hematology workstation. Computer systems monitor the process and equipment, track the specimen, manage inventory, and interpret patient results. When a specimen arrives at the laboratory, the bar-code determines which workcell the specimen should go to for testing. Each specimen is handled individually and in real-time. Hematology specimens are routed to a workcell of Coulter STKS analyzers where complete blood counts with five-part leukocyte differentials are performed under full robotic control. The entire process is managed by a real-time Windows-based process control system that interacts with a networked laboratory information system. The hematology workstation is being evaluated for interpretive results reporting and to determine follow-up testing.

Clinical Laboratory Information Systems↗
PubMed1997

[Principles of creating software and equipment for automating the workplace of laboratory physician].

Automation of laboratory tests is a pressing problem of today, for examinations of the hemopoietic system is a priority in the diagnosis of the majority of diseases and in detecting the effects of unfavorable ecological factors on man; in addition, laboratory studies are time- and labor-consuming. A system "Automated Work Place of a Laboratory Physician" has been developed, which permits automated scanning of a routinely stained blood smear with automated focussing on the detected objects. A preset number of objects is filed in the archive for further identification by a morphologist. The results can be stored in the information database for each patient and be transferred through telecommunication network. The system includes a computer hypertext Blood Atlas.

Automation↗