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PubMed1993

Physician office laboratory regulation: proven strategies to meet the demands of the CLIA (Clinical Laboratory Improvement Amendments).

This article outlines the requirements of the Clinical Laboratory Improvement Amendments, as implemented by regulations that became effective in late 1992. Background information about the statute and a description of the laboratory director's role are provided, and proven strategies for meeting the regulations' quality assurance requirements are discussed in detail.

Clinical Laboratory Techniques↗
PubMed1996

Clinical laboratories are laboratories for re-engineering.

The concept of re-engineering rests on computer coordination of information. As a management tool, it has been tested and found to be ambiguous. At best it sharpens laboratory objectives, but at worst it fragments skills and threatens the community attitudes needed for teamwork. Experience with its most fruitful components has long been a part of laboratory management.

Biomedical Engineering↗
PubMed1993

Guidelines for continuous quality improvement in the cardiac catheterization laboratory. Laboratory Performance Standards Committee of the Society for Cardiac Angiography & Interventions.

The Laboratory Performance Standards Committee of the Society for Cardiac Angiography and Interventions has compiled guidelines for a quality improvement program for the cardiac catheterization laboratory. The first step is to identify "quality indicators" in order to quantify the results. The indicators must be risk-adjusted to assure validity of comparative data. The second step is development of a data collection process that continues after the patient has left the catheterization laboratory. The third step, data evaluation, requires determination of normal ranges of occurrence rates and identification of adverse events that exceed these rates. An investigation should be undertaken to determine the processes and systems that may produce the undesirable outcome. The fourth step is creation of a solution to correct the deficiency. This may involve education, administrative intervention, or feedback. The final step is reassessment of the quality indicators to determine if the corrective action has been effective.

Cardiac Catheterization↗
PubMed1999

[Laboratory findings in elderly patients: a forgotten aspect of laboratory medicine?].

Reference values, which would be related to the individual "biological age" and which would be needed for laboratory investigations of geriatric patients, are at the moment not usual. Thereafter, for rational interpretation of laboratory results, the knowledge of "preanalytical variations" is of crucial importance. These are systematically discussed in the present contribution. In principle, one distinguish between "biological variations" and "preanalytical errors". The first are characterized by the following "factors": "permanent" (age, genetics), "long time" (age), "intermediate" (life style, climate, nutrition), and "short time" (circadian, postprandial, and orthostatic effects). The significance of "preanalytical errors" is accentuated by the fact that many of "geriatric institutions" are serviced by the laboratories, which are not situated close to them.

Aged↗
PubMed1982

Laboratory diagnosis of smallpox: role of the Virus Reference Laboratory, Colindale, 1947-70.

The Virus Reference Laboratory, Colindale, first embarked on laboratory investigations for smallpox early in 1947. From then, in conjunction with the Department of Bacteriology, University of Liverpool, it provided a complete diagnostic service throughout England and Wales until 1962, after which the service became available regionally until eradication was effected. Up to 1970 it had investigated 2696 specimens from suspected cases of smallpox and had recovered 108 strains of variola and 248 of vaccinia virus. These last were from persons suffering the complications of vaccination. Some outbreaks following smallpox importation are discussed but infection among laboratory staff during this period was not demonstrated.

England↗
PubMed1987

Evaluation of a laboratory system intended for use in physicians' offices. II. Reliability of results produced by health care workers without formal or professional laboratory training.

The Kodak DT-60 tabletop chemistry analyzer was evaluated with standardized protocols to determine the system's precision and accuracy when operated by four volunteers (a secretary, a licensed practical nurse, and two family medicine residents) in a simulated office laboratory. The variability of the results was found to be significantly greater than the variability of results produced by medical technologists who analyzed the same samples during the same study period with another DT-60 placed in the hospital laboratory. The source(s) of increased variance needs to be identified so the system can be modified or new control procedures can be developed to ensure the reliability of results used in patient care. Prospective purchasers, manufacturers, and patients need this kind of objective information about the reliability of results produced by systems intended for use in physicians' office laboratories.

Autoanalysis↗
PubMed1986

[Redundancy reduction in laboratory studies--evaluated by the laboratory diagnostic follow-up program of an epidemiologic cardiovascular study].

In addition to our information about significant relations of certain laboratory parameters concerning probationers suspected of heart and vessel diseases, who were identified by means of x-ray screening (EBMO-Cor Berlin) is reported on laboratory parameters applied to follow-up examinations, which proved to be redundant for what was expected (referring the heart and vessel diseases). It refers to the parameters of total protein in the serum, serum electrophoresis, zinc-sulphate test, hematocrit and hemoglobin. The results are supported by mathematic--statistical returns. With regard to the exponential laboratory load in the result of screening and follow-up examination under suspicion of heart and vessel disease the necessity of such considerations is underlined. The statement gains in its significance by the original material concerning the population.

Blood Chemical Analysis↗
PubMed1998

College of American Pathologists Conference XXXI on laboratory monitoring of anticoagulant therapy: laboratory monitoring of unfractionated heparin therapy.

OBJECTIVE: To review the state of the art as reflected in the medical literature and the consensus opinion of recognized experts in the field regarding the laboratory monitoring of unfractionated heparin therapy. DATA SOURCES, EXTRACTION AND SYNTHESIS: The authors made an extensive review of the literature. The draft manuscript was circulated to every participant in the consensus conference prior to the convening of the conference. Extensive discussion concerning all of the issues addressed in the manuscript as well as the resulting recommendations occurred. This information was then used to revise the manuscript into its final form. CONCLUSIONS: The resulting manuscript has 23 specific recommendations regarding preanalytic, analytic, and postanalytic phases of monitoring and testing for complications related to unfractionated heparin therapy. This report contains detailed discussion of these recommendations and includes literature citations that support them. A number of issues for which consensus could not be reached are also discussed. A method is provided to assist laboratories, particularly small laboratories, in providing clinicians with an appropriate therapeutic range for the activated partial thromboplastin time, the most commonly used test in monitoring heparin therapy.

Blood Coagulation Tests↗
PubMed1998

College of American Pathologists Conference XXXI on laboratory monitoring of anticoagulant therapy: the clinical use and laboratory monitoring of low-molecular-weight heparin, danaparoid, hirudin and related compounds, and argatroban.

OBJECTIVE: To review the role of the laboratory in monitoring therapy with low-molecular-weight heparin, danaparoid, hirudin, and argatroban, as reflected in the medical literature and the consensus opinion of recognized experts in the field. DATA SOURCES: Review of the medical literature and current clinical practice by a panel of 6 international experts in the field of anticoagulant therapy. DATA EXTRACTION AND SYNTHESIS: The experts made an extensive review of the published literature and prepared a draft manuscript, which included preliminary recommendations. The draft manuscript was circulated to participants in the College of American Pathologists Conference XXXI on Laboratory Monitoring of Anticoagulant Therapy prior to the conference. The manuscript and recommendations were then presented at the Conference for discussion. Recommendations were accepted if a consensus of the 26 experts attending the Conference was reached. The results of the discussion were used to revise the manuscript into its final form. CONCLUSIONS: This report reviews the mechanism of action and potential uses of these newer anticoagulant agents. General guidelines for monitoring these agents and 9 specific recommendations for laboratory monitoring of low-molecular-weight heparin and danaparoid are provided, along with citation of the appropriate supporting literature. Issues for which a consensus was not reached at the Conference are also discussed.

Anticoagulants↗
PubMed2002

Reduction of exposure to laboratory animal allergens in a research laboratory.

OBJECTIVES: The purpose of this study was to determine exposure levels in the laboratory during different tasks and evaluate the effectiveness of safety equipment used to reduce personal exposure. METHODS: Personal and stationary air samples were collected during different tasks in a laboratory animal facility in which several allergen reduction strategies had been implemented. Mouse urinary allergen concentrations were measured using a polyclonal sandwich enzyme-linked immunosorbent assay. Sera from the personnel (n = 29) were analysed every 6 months for the presence of specific antibodies against mouse and rat urinary allergens, and the staff answered questionnaires on work-related symptoms, exposure and use of respiratory protection. RESULTS: The highest airborne mouse allergen levels were measured during manual emptying of cages, during changing of cages on an unventilated table and during handling of male animals on an unventilated table. Automatic emptying and cleaning of cages resulted in low airborne allergen levels in the working room. Using a ventilated cage-changing wagon reduced the allergen exposure level from 77 to 17 ng/m3. The housing of animals in ventilated cabinets, with air exhausted through the cabinet, effectively prevented the release of allergens into the ambient air. The handling of animals on ventilated benches and the use of a centralized vacuum cleaner resulted in a low exposure level. Only two subjects developed specific immunoglobulin E of > 0.35 kU/l, of whom one was reduced to negative after increased use of respiratory protection. CONCLUSIONS: Effective reduction of exposure to allergens can be achieved by several strategies, which together appear to minimize sensitization to rodents.

Air Pollutants, Occupational↗
PubMed2003

Guidelines for the laboratory investigation of inherited thrombophilias. Recommendations for the first level clinical laboratories.

Recent advances in the laboratory diagnostic approach to inherited thrombophilia call for an update on laboratory strategies and organization. The present paper therefore deals in particular with: the panel test choice, timing and test appropriateness, and analytical methods in several clinical conditions. Specific recommendations are supported by the state-of-the-art in this branch.

Antithrombin III Deficiency↗
PubMed1995

Quality systems for the clinical laboratory. Canadian Society of Laboratory Technologists Working Group.

This paper has outlined some of the factors which have given rise to the interest in TQM which is evidenced by changing accreditation requirements and widespread implementation in health care facilities. Implementation of TQM in the clinical laboratory is dependent upon: 1. A clear focus on the most important aspects of the service we provide, where if quality fails patient care would be most seriously effected (high volume procedures, high risk and/or problem prone). 2. A focus on the customers of our services: ensuring that process improvements address their requirements. 3. A new leadership philosophy: tapping into the expertise of each member of the team to achieve service improvements. 4. Recognition of the importance of interdisciplinary and/or multidisciplinary collaboration: closing the gaps in our existing QA programs and ensuring that quality is defined in terms of the broad experience of patients receiving health care. 5. Taking advantage of staff development in the use of team tools to provide teams the opportunities to be successful in collaborative projects. 6. Demonstrating perseverance and commitment to quality improvement. Giving the process time to demonstrate success. The methods and tools used to accomplish the transformation from quality assurance to TQM are various. The important point for laboratory professionals is to ensure that our plans are consistent with the total quality picture for patient care. To do this will require collaboration, coordination and communication between the various care givers with whom we interact. It will also require recognition that no one health care process stands alone: quality patient care requires an intersection of processes that ensures our ultimate customer, the patient, of service that will meet expectations and will produce a successful outcome.

Canada↗
PubMed2002

Development of a trace gas stable isotope capture system in a mobile laboratory for temporal and spatial sampling of field and laboratory experiments.

We describe the development of a novel mobile field laboratory, purposely designed for the automated capture and subsequent stable isotopic analyses of multiple gas samples. The multiple capture system is integrated into a mobile laboratory that is fully capable of measuring the concentration of carbon dioxide, methane and nitrous oxide trace gases in a flow-through system connected to a gas chromatograph fitted with both electron capture and flame ionisation detectors. The capture of gases is achieved by routing samples through a series of 135 mL gas flasks that are sealed by micro-solenoid valves triggered by a timing system. Trace gas light stable isotope ratio mass spectrometry can then be carried out on gas samples collected by the system (NERC (15)N Stable Isotope Facility). The excitingly unique potential of the system to the ecological research field is that it will allow the collection of cyclical data for three different trace gases both in real-time and in situ. We present data arising from the validation of this mobile system as well as a preliminary experimental assessment of this technique. This technique was used to measure delta(13)C in CO(2) and CH(4) in soil gases released from waterlogged cores and delta(13)C-CH(4) values were significantly depleted in wet cores compared with dry ones (p < 0.001).

Carbon Dioxide↗
PubMed2004

[The "incorrect" laboratory result. II: Common misinterpretations of laboratory results].

In the second part of our review the most frequent misinterpretations of laboratory results in the daily clinical practise are discussed. Special attention has been given to frequent misinterpretations in the analysis of electrolytes, enzymes and hormones in plasma/serum (pseudohyperkalemia, macroenzymes, macroprolactinemia). Misinterpretations of the testing of blood gases, serum glucose, lipid concentrations, and calcium are described in greater detail. In addition, potential errors in the urinanalysis and the importance of adequate sampling of blood specimens for coagulation testing are described. The hematological results can be misinterpreted in the presence of EDTA-induced pseudothrombocytenia and of irregular immunoglobulines. Immunological methods themselves can lead to misinterpretations of the laboratory result, e. g. caused by the high dose hook effect and interferences in the presence of rheumatoid factor or HAMA. Finally clinical relevant errors in the therapeutic drug monitoring are discussed which are associated with the limited specificity of the antibodies in the commonly used immunological tests.

Clinical Laboratory Techniques↗
PubMed2006

Inter-laboratory comparison of NO2 and SO2 generated by dynamic dilution system under laboratory conditions: a technical discussion.

A workshop on analytical quality control (AQC) of ambient air quality measurement methods for nitrogen dioxide (NO(2)) and sulphur dioxide (SO(2)) was conducted by Central Pollution Control Board (CPCB) for officials involved in National Ambient Air Quality Monitoring (NAAQM) in India. Concentrations of NO(2) and SO(2) were generated by dynamic dilution system under laboratory conditions at low and high levels and measured using static dilution system and wet chemical methods laid down by CPCB under section 16(2)(h) of the air act 1981. CPCB provided the measured values as reference values for comparing the means obtained by the officials participated from thirteen organizations. A tolerance limit of +/-15% of the reference values was specified to accept the results. Generated concentrations, which were unknown to the participants, were measured using gaseous sampling assembly (Envirotech APM 411, New Delhi, India), and wet chemical methods laid down by CPCB i.e. the same methodology which is used by the organizations to generate the data of NO(2) and SO(2) in ambient air. Simultaneously, concentrations were checked by CPCB using automatic analyzers as a check on reference concentration. It is observed that results of automatic analyzers for NO(2) and SO(2) were within a tolerance of +/-5% with %RSD below 3. On the other hand, results of most of the participants showed variability in the measurements with %RSD ranging between +/-0.8 and +/-88.6 and exceedences of means from the tolerance limit with bias ranging between 1.4 and -59%. To check the cause of high variability in the measurements obtained under identical conditions, duplicate sampling was performed by one of the participants for SO(2) at low concentration level. In this study, results of wet chemical methods, automatic analyzers and results of duplicate sampling are analysed statistically to assess the cause of high variability in the measurements. Analysis of t-test and analysis of variance (ANOVA) showed highly significant results for NO(2) and SO(2) at high concentration levels (alpha 0.05) and for SO(2) at both the levels (alpha 0.01) respectively indicating some bias is existing either in the sampling or in analytical technique. Duplicate sampling performed to check precision in parallel measurements showed high %RSD indicating the presence of systematic error in sampling technique as the same calibration factor (CF) was used to measure the concentration of duplicate samples. Statistical analysis of flow rates of duplicate sampling showed that the sampling assembly could not maintain the constant flow rate within the +/-10% with that measured at the start of the sampling. This resulted in high %RSD and deviation from the reference values for the results of most of the participants, even after accepting +/-15% tolerance limit. There is a need to improve and evaluate this gaseous sample collection device under laboratory conditions to generate reliable database of NO(2) and SO(2) in ambient air.

Analysis of Variance↗
PubMed1996

Implementation of internal laboratory quality control procedures for the monitoring of ELISA performance at a regional veterinary laboratory.

Quality control (QC) procedures for antigen detection enzyme-linked immunosorbent assays (ELISAs) for hog cholera (HC) virus, foot and mouth disease (FMD) virus, and an antibody detection ELISA for FMD virus were established at a regional veterinary laboratory in northern Thailand. A recently developed computer software package, QCEL, was used to facilitate management and analysis of QC data. The program was used to assess test performance by producing Shewhart-CUSUM control charts which monitored control data for unacceptable fluctuations or trends. QCEL-generated control charts and analyses are presented and discussed. The use of a simple integrated computerised system for storage and analysis of QC control data provided the laboratory with the opportunity to achieve increased confidence in the results of tests performed.

Animals↗
PubMed2003

The effects of total laboratory automation on the management of a clinical chemistry laboratory. Retrospective analysis of 36 years.

BACKGROUND: Thirty-six years of data and history of laboratory practice at our institution has enabled us to follow the effects of analytical automation, then recently pre-analytical and post-analytical automation on productivity, cost reduction and enhanced quality of service. METHODS: In 1998, we began the operation of a pre- and post-analytical automation system (robotics), together with an advanced laboratory information system to process specimens prior to analysis, deliver them to various automated analytical instruments, specimen outlet racks and finally to refrigerated stockyards. By the end of 3 years of continuous operation, we compared the chemistry part of the system with the prior 33 years and quantitated the financial impact of the various stages of automation. RESULTS: Between 1965 and 2000, the Consumer Price Index increased by a factor of 5.5 in the United States. During the same 36 years, at our institution's Chemistry Department the productivity (indicated as the number of reported test results/employee/year) increased from 10,600 to 104,558 (9.3-fold). When expressed in constant 1965 dollars, the total cost per test decreased from 0.79 dollars to 0.15 dollars. Turnaround time for availability of results on patient units decreased to the extent that Stat specimens requiring a turnaround time of <1 h do not need to be separately prepared or prioritized on the system. CONCLUSIONS: Our experience shows that the introduction of a robotics system for perianalytical automation has brought a large improvement in productivity together with decreased operational cost. It enabled us to significantly increase our workload together with a reduction of personnel. In addition, stats are handled easily and there are benefits such as safer working conditions and improved sample identification, which are difficult to quantify at this stage.

Automation↗
PubMed2003

Detection of antimicrobial resistance by small rural hospital microbiology laboratories: comparison of survey responses with current NCCLS laboratory standards.

Microbiology laboratory personnel from 77 rural hospitals in Idaho, Nevada, Utah, and eastern Washington were surveyed in July 2000 regarding their routine practices for detecting antimicrobial resistance. Their self-reported responses were compared to recommended laboratory practices. Most hospitals reported performing onsite bacterial identification and susceptibility testing. Many reported detecting targeted antimicrobial resistant organisms. While only 5/61 hospitals (8%) described using screening tests capable of detecting all 8 targeted types of resistance, most (57/61, 93%) were capable of accurately screening for at least 6 types. Conversely, most hospitals (58/61, 95%) reported confirmatory testing capable of identifying only 3 or fewer resistance types with high-level penicillin resistance among pneumococci, methicillin and vancomycin resistance among staphylococci and enterococci, and extended spectrum beta-lactamase production by Gram-negative bacilli presenting the greatest difficulties. Furthermore, only 50% of hospitals compiled annual antibiogram reports to help physicians choose initial therapy for suspected infectious illnesses. This survey suggests that the antimicrobial susceptibility testing in many rural hospitals may be unreliable.

Anti-Bacterial Agents↗