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PubMed2004

A comparison of instruments and laboratories used to measure milk urea nitrogen in bulk-tank milk samples.

The objective of this study was to compare the instruments and laboratories that are currently used for analysis of milk urea nitrogen (MUN) for bulk-tank milk samples. Two replicate samples from each bulk tank on 10 different dairy farms were sent to 12 Dairy Herd Improvement Association (DHIA) laboratories throughout the US for MUN analysis. Two laboratories used 2 different methods for MUN analysis for a total of 14 analyses on 20 samples (n = 280). Values of MUN were analyzed using a random effects model with farm, laboratory, and farm x laboratory variance components. Greater than 98% of the variance in measured MUN was attributed to farm-to-farm variance for analysis of MUN by the Bentley, CL 10, Foss 6000, and Skalar instruments. However, for the laboratories using the Foss 4000 system, <60% of the variance in MUN was attributed to farm-to-farm variance. Laboratories using the Bentley, CL 10, Foss 6000, and Skalar instruments provided slightly different results for MUN analysis, but >95% of sample measurements fell within 1.75 mg/ dL of each other. The laboratories using Foss 4000 differed from each other, and 95% of samples fell within 5 mg/dL of the CL 10 measurement. Laboratories using the Foss 4000 instrument did not consistently provide measurements of MUN that were similar to each other or to the measurements of the other instruments.

Animals↗
PubMed2001

Viral load test reports: a description of content from a sample of US laboratories.

CONTEXT: Human immunodeficiency virus (HIV) RNA testing (viral load testing) is increasingly important in the care of patients infected with HIV-1 to determine when to initiate, monitor, and change antiretroviral therapy. Patient viral load testing information is communicated to the clinician through the laboratory test report. OBJECTIVES: To examine the format and information used in reporting viral load testing results and determine the clarity of the information provided in these reports. DESIGN: Patient test reports with all personal identifiers removed were requested of viral load testing laboratories participating in a telephone survey of laboratory practices. Hospital, independent, health department, and "other type" laboratories identified as university-associated laboratories participated in the telephone survey. RESULTS: Thirty-seven unique test reports were collected. All laboratories reported results in copies/mL, while 14% also reported results as "log(10) copies/mL." The test kit was identified by only 24% of the laboratories. Reportable ranges were specified by 70% of the laboratories, but there was considerable variation in terminology. One laboratory reported a viral load copy number below the manufacturer's test kit lower limit of sensitivity. The layout and format differed among reports. Some results were expressed in log(10), others contained nonsignificant integers, while others contained exponential numbers. Supplemental information in some reports included previous patient test results and significance of changes from baseline. The format of some reports made it difficult to read the report information and interpret the testing results. CONCLUSION: This study emphasizes the importance of standardizing the reporting of HIV-1 viral load test results to minimize result misinterpretation and incorrect treatment.

Data Collection↗
PubMed2002

Q-tracks: a College of American Pathologists program of continuous laboratory monitoring and longitudinal tracking.

CONTEXT: Continuous monitoring of key laboratory indicators of quality by hundreds of laboratories in a standardized measurement program affords an opportunity to document the influence of longitudinal tracking on performance improvement by participants focused on that outcome. OBJECTIVE: To describe the results of the first 2 years of participation in a unique continuous performance assessment program for pathology and laboratory medicine. DESIGN: Participants in any of 6 modules in the 1999 and 2000 College of American Pathologists (CAP) Q-Tracks program collected data according to defined methods and sampling intervals on standardized input forms. Data were submitted quarterly to CAP for statistical analysis. Interinstitutional comparison reports returned in 6 weeks provided each laboratory with its performance profile of key indicators and its percentile ranking compared with all participants in that quarter. This also included longitudinal comparisons of performance during previous cumulative quarters. Control charts graphically displayed data with flags identifying performance points that were out of statistical control. SETTING: Hospital-based laboratories in the United States (98%), Canada, and Australia. PARTICIPANTS: Voluntary subscriber laboratories in the CAP Q-Tracks performance measurement program: roughly 70% from hospitals of 300 occupied beds or fewer, 65% from private, nonprofit institutions, slightly more than half located in cities, one third from teaching hospitals, and 20% with pathology residency training programs. MAIN OUTCOME MEASURES: Each module measured several major and additional minor quality indicators and unbenchmarked individualized data for internal use. RESULTS: Participants in 4 of 6 Q-Tracks continuous monitors demonstrated statistically significant performance improvement trends in 1999 and 2000, which were most marked for laboratories that continued participation throughout both years. These monitors were wristband patient identification, laboratory specimen acceptability, blood product wastage, and intraoperative frozen section consultation. CONCLUSIONS: Key continuous indicators chosen on the basis of a decade's experience in the CAP Q-Probes quality improvement program are useful measurement and benchmarking tools for laboratories to improve performance. In general, measures in which there is a broad range of demonstrable performance initially are most optimal for subsequent improvement using continuous monitoring. These studies have shown that quality is not static, but rather is a moving benchmark of performance as seen in the redefinition of benchmarks over time by participants in the first 2 years of the CAP Q-Tracks program.

Accreditation↗
PubMed2004

Analysis of on-line clinical laboratory manuals and practical recommendations.

CONTEXT: On-line clinical laboratory manuals are a valuable resource for medical professionals. To our knowledge, no recommendations currently exist for their content or design. OBJECTIVE: To analyze publicly accessible on-line clinical laboratory manuals and to propose guidelines for their content. DESIGN: We conducted an Internet search for clinical laboratory manuals written in English with individual test listings. Four individual test listings in each manual were evaluated for 16 data elements, including sample requirements, test methodology, units of measure, reference range, and critical values. Web sites were also evaluated for supplementary information and search functions. RESULTS: We identified 48 on-line laboratory manuals, including 24 academic or community hospital laboratories and 24 commercial or reference laboratories. All manuals had search engines and/or test indices. No single manual contained all 16 data elements evaluated. An average of 8.9 (56%) elements were present (range, 4-14). Basic sample requirements (specimen and volume needed) were the elements most commonly present (98% of manuals). The frequency of the remaining data elements varied from 10% to 90%. CONCLUSIONS: On-line clinical laboratory manuals originate from both hospital and commercial laboratories. While most manuals were user-friendly and contained adequate specimen-collection information, other important elements, such as reference ranges, were frequently absent. To ensure that clinical laboratory manuals are of maximal utility, we propose the following 13 data elements be included in individual test listings: test name, synonyms, test description, test methodology, sample requirements, volume requirements, collection guidelines, transport guidelines, units of measure, reference range, critical values, test availability, and date of latest revision.

Abstracting and Indexing↗
PubMed2005

Staffing benchmarks for clinical laboratories: a College of American Pathologists Q-probes study of staffing at 151 institutions.

CONTEXT: Inadequate staffing of clinical laboratories may compromise quality and throughput, whereas excess staff unnecessarily increases the cost of testing. OBJECTIVES: To measure productivity of technical staff and management span of control in a large number of laboratories and to determine factors associated with favorable staffing ratios. DESIGN: A total of 151 clinical laboratories provided information about technical and management staffing and output (workload) for 4 laboratory sections: anatomic pathology, chemistry/hematology/immunology, microbiology, and transfusion medicine. RESULTS: For each laboratory section, there was wide variation in labor productivity (output per nonmanagement full-time equivalent) and in management span of control (nonmanagement full-time equivalent per manager). Productivity ratios for the 10th- and 90th-percentile laboratories varied more than 3-fold. Except in histology, laboratory sections with higher test volumes had higher labor productivity (P < .001 for cytology, chemistry/hematology, and transfusion medicine; P = .003 for microbiology). Even within peer groups composed of sections with similar volume, there was wide variation in labor productivity. A number of variables other than test volume were associated with labor productivity and management span of control. Staffing ratios for each laboratory section and for sections of different sizes are presented. CONCLUSIONS: Despite standardization of testing methods in the clinical laboratory industry, there is wide variation in staffing level among institutions. This variation suggests opportunities to improve staff productivity in many facilities.

Benchmarking↗
PubMedDate not supplied

Laboratory cost and utilization containment.

The authors analyzed laboratory costs and utilization in 3,771 cases of Medicare inpatients admitted to a New England academic medical center ("the Hospital") from October 1, 1989 to September 30, 1990. The data were derived from the Hospital's Decision Resource System comprehensive data base. The authors established a historical reference point for laboratory costs as a percentage of total inpatient costs using 1981-82 Medicare claims data and cost report information. Inpatient laboratory costs were estimated at 9.5% of total inpatient costs for pre-Diagnostic Related Groups (DRGs) Medicare discharges. Using this reference point and adjusting for the Hospital's 1990 case mix, the "expected" laboratory cost was 9.3% of total cost. In fact, the cost averaged 11.5% (i.e., 24% above the expected cost level), and costs represented an even greater percentage of DRG reimbursement at 12.9%. If we regard the reimbursement as a total cost target (to eliminate losses from Medicare), then that 12.9% is 39% above the "expected" laboratory proportion of 9.3%. The Hospital lost an average of $1,091 on each DRG inpatient. The laboratory contributed 29% to this loss per case. Compared to other large hospitals, the Hospital was slightly (3%) above the mean direct cost per on-site test and significantly (58%) above the mean number of inpatient tests per inpatient day compared to large teaching hospitals. The findings suggest that careful laboratory cost analyses will become increasingly important as the proportion of patients reimbursed in a fixed manner grows. The future may hold a prospective zero-based laboratory budgeting process based on predictable patterns of DRG admissions or other fixed-reimbursement admission and laboratory utilization patterns.

Academic Medical Centers↗
PubMedDate not supplied

Outreach, consolidation, and networking: Columbia's approach to successful integration of laboratory services in California.

At the forefront of integrated laboratory services, Columbia Bay Area Healthcare Network's Lab Link provides a unique approach to operating hospital-based laboratories in today's heavily penetrated managed-care environment. Columbia recognizes that a combined strategy of laboratory consolidation, outreach, and networking is essential to compete successfully with commercial reference laboratories for local and statewide contracts. Implementing this model enables hospital laboratories to produce high quality, cost-effective test results while increasing volume and reducing duplication. When hospital laboratories consolidate and network with local and regional laboratories, inpatient and outpatients information is cross-fertilized through a web of information systems. Patients information can then be accessed easily and monitored throughout the continuum of care. The goal of this article is to provide hospital laboratories with a streamlined approach to structuring and delivering services while maintaining a competitive edge in the tumultuous healthcare market. The future of laboratory services within the hospital setting lies in the aggressive use of three elements--consolidation, outreach, and networking--to ensure quality service as well as economic viability.

California↗
PubMedDate not supplied

Laboratory proficiency testing of aflatoxins in corn and peanuts--a cooperative project between Thailand and the United States.

The objective of this project was to conduct an aflatoxin proficiency test program in government, academia, and industry laboratories in Thailand. Aflatoxin-free corn and peanuts and corn and peanuts naturally contaminated with aflatoxins diluted to approximately 25 micrograms/kg were analyzed. Homogeneity of prepared, naturally contaminated test samples was checked on multiple replicates. The test was conducted according to the ISO/IUPAC/AOAC INTERNATIONAL Harmonized Protocol with z scores indicating laboratory performance. The participants used 3 methods: enzyme-linked immunosorbent assay, thin-layer chromatography, and the minicolumn. Of 19 laboratories that reported results for aflatoxins in naturally contaminated corn, 13 (68%) performed satisfactorily, on the basis of the mean obtained by an expert laboratory, a calculated target value for standard deviation, and the z score. Of 21 laboratories that reported results for aflatoxins in naturally contaminated peanuts, 10 (48%) performed satisfactorily. For aflatoxin-free corn, 6 laboratories reported finding aflatoxins at > or = 10 ng/g, chiefly by the minicolumn method; for aflatoxin-free peanuts, 1 laboratory reported finding aflatoxins at > 10 ng/g. Subsequently, a workshop of lectures and laboratory sessions was conducted to improve performance. A new and simple successive outlier removal procedure applied to the same data removed the same laboratories as did the use of z scores.

Aflatoxins↗
PubMedDate not supplied

Health and safety in clinical laboratory practice in Ibadan, Nigeria.

The economic implications of safety precautions in laboratory practice make compliance difficult especially for laboratories in countries with poor economies. However, economic factors are not the only determinants of a safe work environment. Worker's perception of health and safety also influence compliance with safety guidelines. This study was conducted to determine the attitude and practice of laboratory workers with regard to safety. A structured questionnaire was administered to laboratory workers in 10 clinical laboratories. The questionnaire inquired about the use of protective equipment, safe work practices and immunization status of workers. Another questionnaire sought information on safety codes, accident records and first aid facilities in each laboratory. Questionnaires were coded and analysed. Ninety out of 106 laboratory workers (85%) responded to the inquiry. Unsafe work practices such as eating or drinking in laboratories and mouth pipetting of biological samples were practised by 41% and 10% of workers, respectively. Ninety percent of workers used white coats while 64% used gloves when handling biological samples. None of these workers used goggles or face shields in the course of their work. Fifty-one percent had received immunisation against tuberculosis, 73% against tetanus and 16% against hepatitis B. Thirty-seven percent of senior staff and 72% of junior staff did not receive any formal safety training. Accident records and first aid facilities were absent in most laboratories. The commonest health problem reported by workers was low back pain. The poor coverage of hepatitis B immunization among health care workers in an endemic area is currently a cause for concern among medical and paramedical staff. There is a need for education programmes to increase awareness on safety. Occupational health workers in this setting face the challenge of promoting safe work practices among workers in the face of the lack of funding and apathy among poorly paid junior workers.

Adult↗
PubMed2000

Laboratory policies on testing for rotavirus affect surveillance data. PHLS East Epidemiology and Virology Subcommittees.

The effect of different laboratory testing policies on the surveillance of rotavirus was assessed in eight laboratories between 1995 and 1998. In 1995, five laboratories tested all faecal specimens from children aged 5 years and under all year, two tested all specimens from children aged 4 years and under all year, and one tested all specimens from children aged 3 years and under between November and May only. Five laboratories changed their testing policy between 1995 and 1998. By 1998, three tested all specimens from children aged 5 years and under all year and two from the same age group during the 'season' only. Three laboratories had unique policies: one tested all specimens from children aged 2 years and under between January and June, one tested all specimens from children aged 4 years and under all year, and one tested specimens only on clinical request. The onset date of the rotavirus infection 'season' as determined by retrospective scrutiny of reported cases varied by up to 15 weeks between laboratories, starting as early as week 45 (November) and as late as week 13 (March). Laboratories with more restrictive testing policies yielded fewer reports of rotavirus and changes in policy within a particular laboratory affected the number of reports. Temporal and geographic trends were visible, even within the relatively small area covered by this study, and showed how laboratory testing policies affect surveillance data.

Age Distribution↗
PubMed2000

Information system issues facing clinical laboratories serving complex integrated delivery systems.

Laboratory information systems (LISs) have evolved into complex applications to meet the specialized needs of laboratories. As integrated delivery systems (IDSs) continue to emerge as a dominant model for healthcare delivery, clinical laboratories serving them face two imperatives that affect IS decisions. First, laboratories in IDSs must consolidate to reduce costs and duplication yet deliver service across a region in both inpatient and outpatient settings. Second, laboratories that successfully perform reference laboratory testing will increase revenue, generate referrals, and leverage excess capacity, and may provide a competitive advantage for the IDS. This article examines laboratory information management in complex IDSs, presents options for IS support of consolidating or integrating laboratory operations, and reviews functionality requirements for laboratory outreach activities.

Clinical Laboratory Information Systems↗
PubMedDate not supplied

External quality control program for inter-laboratory quality control.

BACKGROUND: The accuracy and precision of tumor marker testing is of high clinical importance requiring the implementation of effective quality control procedures in the diagnostic laboratory. An external quality control program including an inter-laboratory comparison could be of help in improving the quality of test results. MATERIALS AND METHODS: Laboratories using BIOREF reference material sent their routine internal quality control results of each monthly control period to the evaluation center for statistical analysis and inter-laboratory comparison. RESULTS: The inter-laboratory comparison showed that the mean values of test results obtained by different laboratories can vary considerably especially when different test kits are used. A comparison of test results of laboratories using the same test kit showed much better correlation but discrepancies of coefficients of variation between these laboratories were still observed. CONCLUSION: An external quality control program revealed problems in the accuracy and precision of tumor marker test results in the individual laboratory, which could serve as a basis for the improvement of test performance.

Biomarkers, Tumor↗
PubMedDate not supplied

Making performance-based chemistry work: how we created comparable data among laboratories as part of a Southern California marine regional assessment.

Quality assurance procedures to ensure consistency among chemistry laboratories typically involves the use of standard methods and state certification programs that require laboratories to demonstrate their ability to attain generic performance criteria. To assess whether these procedures are effective for ensuring comparability when processing local samples with potentially complex matrices, seven experienced, state-certified laboratories participated in an intercalibration exercise. Each laboratory was permitted to use their typical methodology for quantifying PAH, PCB and DDT on shared samples collected from Santa Monica Bay and the Palos Verdes Shelf, two sites with a complex mix of constituents. In the initial intercalibration exercise, results from these laboratories differed by as much as an order of magnitude for all three chemical groups. Much, but not all, of the difference was attributable to differences in detection capability. A series of studies was conducted to identify the reasons for the observed differences, which varied among laboratories and included methodological differences, instrument sensitivity differences, and differing interpretations of chromatograms. Following these investigations and resulting modifications to laboratory procedures, the exercise was repeated. The average coefficient of variation among laboratories across all chemical parameters was reduced to less than 30%. Our results suggest that performance-based chemistry can produce comparable results, but the certification processes presently in place that focus on general laboratory procedures and simple matrices are insufficient to achieve comparability.

Calibration↗
PubMedDate not supplied

New benchmarks and design criteria for laboratory consolidations.

Benchmarks and design criteria previously used for planning consolidated laboratories such as bed size, staffing, and test volumes no longer apply. To achieve greater operational efficiencies, consolidated laboratories should be designed with open, flexible, and adaptable space using work flow/workstations, instrumentation requirements, and the degree of automation as the key design criteria. The primary objective of most consolidations is the reduction of staff with a substantial increase in workload. A critical factor when planning a consolidated laboratory is the ability of the space to accommodate the increase in testing and procedures to serve multiple facilities and growing outreach programs with fewer FTEs. Designing the laboratory starts with a thorough evaluation of work flow, testing procedures, desired adjacencies, and relationships within the laboratory. An area analysis should be developed describing in detail projected space requirements. Consideration should be given for the incorporation of automation/robotics and new, more efficient, and comprehensive instrumentation. Safety, noise, vibration control, lighting, and engineering support systems are all critical issues that also must be effectively addressed and incorporated into the design. Specific issues that will be discussed at this program include projected space requirements; review and development of existing and projected workstations; equipment requirements; lighting options; workload and procedures review; staffing procedures; flexibility/adaptability; relationships and adjacencies; flow diagrams; plan development; cost implications, on-site versus off-site facilities; and new construction versus renovation construction cost comparisons. Using specific examples from consolidated laboratory projects, we have designed a case study presentation by the laboratory director from a recently completed laboratory consolidation project serving a multihospital system. We will discuss the new design criteria and benchmarks that must be established to create a functional, operationally efficient, and profitable laboratory consolidation.

Automation↗
PubMed2002

Application of indicators for quality improvement in the coagulation laboratory.

Indicators are tools that measure work performance and serve as a guide to improve the quality of laboratories. Seven Indicators for quality improvement have been established in our coagulation laboratory. They are :- 1). percentage of pre-analytical problems, 2). personnel competency scores, 3). results of external quality assessment, 4). % coefficient of variation (CV) of control materials, 5). unit cost, 6). percentage of reports within determined time, and 7). percentage of customers who were satisfied. The percentage of preanalytical error gradually decreased from 1.8% in April 2001 to 0.8% in June 2001 as a result of co-operation between the coagulation laboratory and the wards. Since there is no system to check personnel competency at a national level in Thailand, we set up a program for testing personnel competency in our department by asking every technician to take a written and practical laboratory examination. The scores achieved by our personnel ranged from 40 to 90%. For those who achieved scores of lower than 70%, we limited their responsibilities and organized a training program for them. In order to check our laboratory's accuracy, we are enrolled in the WHO International External Quality Assessment Scheme (IEQAS) in Blood Coagulation and have been since 1987. The survey results indicated that most of our laboratory tests were within consensus including our homemade ELISA tests for protein C, protein S and vWF antigen. The percent CVs of control materials used for the internal daily control for every test were analyzed. They ranged from 2.3 for normal APTT to 11.4 for the low level of free protein S in plasma. The unit cost for each test was analyzed to determine the cost-effectiveness of the laboratory. We set the goal for the turn around time for emergency coagulation tests to be within an hour and the percentage of reports within this time was 91.6% in August 2001. The last indicator was the percentage of satisfied customers, which gave an indication of the quality of all Out Patient Department (OPD) services performed by our department. We sent 400 questionnaires to doctors, nurses and patients in OPD asking their opinion of both the technical services and the behavior of our technicians. The percentage satisfaction of our customers concerning services offered to OPD was lower than 50%. We plan to improve the last 2 indicators by expanding the space of the OPD/emergency laboratory and reorganizing the service system. All indicators mentioned above have helped to improve the quality of our laboratory greatly.

Blood Coagulation Tests↗
PubMed2003

[Laboratory accreditation and proficiency testing].

ISO/TC 212 covering clinical laboratory testing and in vitro diagnostic test systems will issue the international standard for medical laboratory quality and competence requirements, ISO 15189. This standard is based on the ISO/IEC 17025, general requirements for competence of testing and calibration laboratories and ISO 9001, quality management systems-requirements. Clinical laboratory services are essential to patient care and therefore should be available to meet the needs of all patients and clinical personnel responsible for human health care. If a laboratory seeks accreditation, it should select an accreditation body that operates according to this international standard and in a manner which takes into account the particular requirements of clinical laboratories. Proficiency testing should be available to evaluate the calibration laboratories and reference measurement laboratories in clinical medicine. Reference measurement procedures should be of precise and the analytical principle of measurement applied should ensure reliability. We should be prepared to establish a quality management system and proficiency testing in clinical laboratories.

Accreditation↗
PubMed2004

[Future of clinical laboratory medicine--review of the system in United States].

As the clinical laboratory medicine is the integral bridge between clinical patient care and basic science, both the high quality patient care service and the active laboratory research challenges are indispensable. This article introduces the state of the department of laboratory medicine in M.D. Anderson Cancer Center (MDACC), Houston, Texas, USA. The department of laboratory medicine in MDACC processes over 4 million tests per year and performs over 1,800 different tests and assays with good cost effectiveness. The laboratory staff carry a heavy patient care service load in addition to laboratory support for the clinical research protocols in the other clinical divisions. Research projects in the laboratory medicine are aimed primarily at establishing new or improved methodologies and procedures for clinical laboratory testing, and evaluation of prototypes for new analytic instruments. Generally, the translation of the research findings into effective clinical laboratory tests is the important approach. The more strength should be on the productive research collaboration with basic science and clinician colleagues.

Clinical Laboratory Techniques↗
PubMed1992

Progress in blood lipid reporting practices by clinical laboratories in North America. Changes from 1985 to 1990.

In an attempt to assess the impact of the National Cholesterol Education Program recommendations and to provide follow-up to a 1985 survey of blood lipid reporting practices in 152 academic clinical laboratories in North America, the same laboratories were resurveyed regarding current blood lipid-reporting practices. All 97 laboratories that responded to our survey routinely measured serum total cholesterol, while 94% measured high-density lipoprotein cholesterol, 99% measured triglycerides, 26% apolipoproteins A1 and B, and a single laboratory measured apolipoprotein E. There was a marked downward shift in reference ranges for serum total cholesterol used by laboratories in 1990 compared with 1985. Of the laboratories responding to both surveys, 90% lowered their reported reference values. Changes in the sources of reference ranges were also noted. The percent of laboratories using reference ranges based on age and sex fell from 52% to 21% and from 31% to 10%, respectively. The number of laboratories designating patient risk for coronary heart disease rose from 31% to 72%. Currently, 61% of laboratories designating risk use the National Cholesterol Education Program guidelines for serum total cholesterol. The use of other risk designations, including high-density lipoprotein--cholesterol, total cholesterol to high-density lipoprotein cholesterol ratio, low-density lipoprotein cholesterol, and apolipoproteins changed only modestly during the 5-year interval. The current reporting patterns reflect simplified and more uniform practices apparently in response to the National Cholesterol Education Program.

Adult↗