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PubMed2002

Practice patterns of testing waived under the clinical laboratory improvement amendments.

OBJECTIVES: To determine operational practices in laboratories operating under a Certificate of Wavier (waived laboratories), or equivalent, under the Clinical Laboratory Improvements Amendments (CLIA) of 1988 when performing tests designated as having an insignificant risk of an erroneous result (ie, waived tests). METHODS: Waived laboratories that were part of the Centers for Disease Control and Prevention Laboratory Sentinel Monitoring Network project in the states of Arkansas, New York, and Washington were surveyed about their quality control (QC) and quality assurances (QA) practices when performing waived testing. Arkansas and Washington sent out similar questionnaires, whereas on-site surveys were conducted in New York. The survey in Arkansas and Washington also included nonwaived laboratories. The New York visits were designed to pilot test a regulatory inspection program for limited testing sites, which, in New York, are roughly equivalent to laboratories operating under a CLIA Certificate of Wavier and/or Provider-Performed Microscopy but are generally not located in physicians' offices. Laboratories visited in New York were selected from a list of limited testing sites and were representative of that population. RESULTS: Arkansas received responses from 211 facilities (37% response rate), of which 38% had Certificates of Waiver. Washington received responses from 190 waived laboratories (71% response rate) and from 116 nonwaived laboratories (32% response rate). In New York, 607 of the 2751 limited testing laboratories were visited. Reporting laboratories in all 3 states most frequently performed testing for glucose, urinalysis, urine human chorionic gonadotropin, occult blood, and group A Streptococcus antigen, although other waived tests were performed less frequently. Washington found that 57% of waived laboratories followed manufacturers' QC requirements. Arkansas found that 58% of laboratories doing waived tests that required liquid controls performed these controls, and 59% performing waived testing requiring electronic controls used these controls. In New York, 68% of the laboratories complied with the manufacturer's QC requirements for a variety of tests. Being accredited by an external organization or affiliated with a more complex laboratory improved compliance. Nonwaived laboratories in Washington and Arkansas complied with manufacturer's instructions at a higher rate than did waived laboratories. Similar deficiencies in following CLIA requirements were found in other areas of laboratory operation. CONCLUSIONS: Just more than half of waived laboratories in 3 diverse states follow manufacturer's instructions for recommended QC and QA. These instructions help ensure that the test will produce results that have an insignificant chance of an error. Although we did not study the impact of this and other findings on patient care, the results show that imposing good laboratory practices by regulation alone was insufficient to ensure quality laboratory results in any location evaluated. A system that can continually provide accessible education on laboratory practices, coupled with new thoughts on the regulatory environment, is in order.

Certification↗
PubMed1998

[Why medical consultation is needed in the clinical laboratory].

During the 20th century, at least until the 1980s, clinical laboratory practice had been rapidly expanded, mainly because of a significant advancement in medicine as a whole and also in laboratory technology. However, recent economic changes in health care environment worldwide have been influencing greatly future trends in clinical laboratory practice. Four major macroeconomic forces drive change in clinical laboratory practice as follows; (1) Increasing cost of health care, (2) Implications of an aging population, (3) Social change in the patient population, and (4) Explosion of new technologies. Obviously, the increasing cost of health care is the primary driver. Considering a rapid change in the health care environment, clearly there are two separate pathways to be considered with regard to future modes of delivering patient care services through the clinical laboratory: commercial independent laboratories and hospital laboratories. In most hospital laboratories, in addition to high-quality, accurate and precise laboratory data being delivered through automated informatics in a timely fashion, laboratory physicians and other laboratorians should be available 24 hours a day and 7 days a week. The primary purpose of this approach is to develop a system in which the physician can order the most efficient number of tests, which will provide the maximum amount of clinically relevant informations most rapidly and most accurately at the least cost to the patient. Laboratory physicians must play a key role particularly in hospital laboratories. Their most important roles include those of a professional supplier of laboratory results being useful for health care and clinically relevant, and that of a consultative role for primary care physicians and other co-medical staffs to make important medical decision, based on laboratory results obtained. Therefore, the Japan Society of Clinical Pathology started in 1990 in publishing a series of proposed guidelines for adequate utilization of laboratory tests in primary health care. Since April, 1997, the Japanese Ministry of Health and Welfare has set a specific fee for the hospitals, where a full-time laboratory physician is responsible for the quality management of its clinical laboratory and the Committee on Adequate Utilization of Laboratory Tests is established in the hospital. For the future 21st Century, laboratory scientists including physicians and technologists must change their concept and attitude in order to provide quality laboratory service with the minimal laboratory cost to the patient.

Clinical Laboratory Techniques↗
PubMed2001

Reference laboratory telephone service quality.

OBJECTIVES: To establish the rates with which reference laboratories resolve inquiries telephoned to them from primary laboratories and to identify reference laboratory practices associated with higher rates of inquiry resolution. DESIGN AND PARTICIPANTS: For 2 months, or until 50 contacts had occurred, 545 primary laboratories participating in the College of American Pathologists Q-Probes laboratory quality improvement program prospectively documented and characterized telephone inquiries they made to a reference laboratory of their choice. Participants also cataloged their own laboratory's demographic and practice characteristics and their reference laboratory's customer service characteristics. MAIN OUTCOME MEASURE: Rates with which reference laboratories resolved telephone inquiries. RESULTS: Participants characterized 11 031 (78.7%) of 14 017 telephone inquiries as resolved by the reference laboratories. Ranked according to inquiry resolution rates, primary laboratories in the 90th percentile characterized reference laboratories as resolving 100% of their inquiries; those in the 10th percentile characterized reference laboratories as resolving only 54.2% of their inquiries. The rate of resolved inquiries was significantly higher (P =.0047) for participants using reference laboratories with 24-hour customer service than it was for participants using reference laboratories with less than 24-hour service. Most primary laboratories (80.9%) chose to monitor 1 of 11 national reference laboratories; in this subset, median rates of inquiry resolution ranged from 90.2% to 55.0% (P <.0001), despite no significant variation in other measured customer service characteristics. CONCLUSIONS: Primary laboratories experience significant differences in the rates with which reference laboratories resolve telephone inquiries. The performance benchmark for reference laboratories is resolution of at least 90% of telephone inquiries from primary laboratory customers.

Humans↗
PubMed1985

Cost-containment and the use of reference laboratories.

Hospital laboratories and hospital-independent reference laboratories will need to change in order to provide comprehensive, medically appropriate, and reasonably priced laboratory services in the cost-containment age we are entering. The change must be economically and technologically innovative and relevant to society's next generation of health care needs. Hospital laboratories and commercial laboratories may become weaker or stronger relative to one another, but our guess is that they will ultimately become more like one another or even may join forces to provide optimal patient care in the future. Until that time comes, hospital laboratories must decide whether to employ reference laboratory services more or less, enter a joint venture with a reference laboratory, or become a reference laboratory. Some of the items that could be considered in arriving at this decision are listed in Table 2. Some items favor hospital laboratories; some favor reference laboratories; some are a toss-up; and some suggest there are advantages in a team approach. For the present, we believe there are many arguments favoring a continuation and possibly even an expansion of hospital laboratory services, but this will likely be most feasible in financially sound and progressive hospitals having forward-looking administrators and imaginative but fiscally minded laboratory directors and managers. If decisions are made to send more tests to reference laboratories, each hospital or user laboratory must seek the best and most cost-effective services available. Various financial, technical, and medical considerations are described that should aid in the evaluation of where to have tests performed. We have provided suggestions on how agreements with reference laboratories can be established in either a formal (contractual) or an informal (verbal) way. Additionally, we have described methods for evaluating (or monitoring) the quality and quantity of services received from a reference laboratory. In general, for any significant agreement with a reputable reference laboratory, little more may be necessary for monitoring purposes than periodic financial and quality assurance audits and follow-up on any clinical complaints regarding test results. With a large contract, the user laboratory is advised to spot check results on submitted blind duplicates of patient samples (to test provider lab precision) and occasionally to split samples between the provider and one or more other reference laboratories (as a first look at possible inaccuracy).(ABSTRACT TRUNCATED AT 400 WORDS)

Clinical Laboratory Techniques↗
PubMedDate not supplied

Clinical laboratory employment and workload patterns.

Determining numbers and types of personnel to staff clinical laboratories is important to employers and educators. At 5-year intervals over the last 25 years, employment patterns among laboratory personnel have been examined in the 5 county Minneapolis-St. Paul (Twin Cities) area that includes 2.2 million persons, almost 50% of Minnesota's population. The 1995 survey was distributed to laboratory administrators of 28 major laboratories. All (100%) responded with information regarding personnel numbers and types. Data from 1995 were compared to that from 1970, 1980, and 1990. In 1970 there were 30 hospitals in the Twin Cities area with over 10,000 hospital beds; there were also 2 blood banks and 4 clinic laboratories. Altogether approximately 1300 laboratorians were employed. In 1980 there were still 10,000 hospital beds among 29 hospitals. However there were 8 other major employers of clinical laboratory personnel, including blood banks, clinics, and a reference laboratory. Between 1970 to 1980, the number of laboratory personnel almost doubled to 2500. The impact of managed care together with the Prospective Payment System, a government initiative of 1983, profoundly affected health care institutions and their personnel. By 1990 hospital mergers and closures reduced the number of Twin Cities hospitals to 20 with a total of 7500 beds. There were 11 blood banks, clinics, reference labs, and HMOs, including 3 reference (independent) laboratories. Laboratory employees increased slightly to 2600. By 1995, hospitals were reduced to 18 and hospital beds to fewer than 7000. The number of all personnel in the 28 laboratories surveyed rose to 2900. Between 1980 and 1995, 10 major hospitals closed or were converted to a different type of facility. Four hospitals merged to form 2 consolidated hospitals. Only 2 small suburban hospitals were built. However, despite the decrease in hospitals, laboratory personnel numbers increased after 1980, due largely to the emergence of 3 independent laboratories, as well as a result of an increase in overall testing volume. Seventy-five percent of the 28 administrators surveyed reported more laboratory testing in 1995 than in 1990. The number of laboratory personnel in the Minneapolis-St. Paul area has more than doubled in the past 25 years, despite the closure of 1/3 of the Twin Cities hospitals and efforts by the government to reduce laboratory testing. One reason for the expanded employment of laboratories and greater testing volume is the expansion of the laboratory itself--into new diagnostic technologies, as well as into new laboratory sites.

Blood Banks↗
PubMed2000

National Inventory of Clinical Laboratory Testing Services (NICLTS). Development and test distribution for 1996.

CONTEXT: A statistically valid inventory of the distribution, both geographic and by laboratory type, of clinical and anatomical laboratory testing in the United States is needed to assess the impact of the Clinical Laboratory Improvements Amendments of 1988 and to provide information for other health care and public health policy decisions. OBJECTIVE: To present initial US laboratory testing volume data compiled by the National Inventory of Clinical Laboratory Testing Services. DESIGN: Stratified random sample of laboratories performing testing in 1996 with data on the number of laboratory tests performed, identified by method and analyte. Data were collected by field tabulators (moderate- or high-complexity laboratories) or through a mail/telephone survey (waived or provider-performed microscopy laboratories) for each site. PARTICIPANTS: Laboratories that were enrolled in the 1996 Online Certification Survey and Reporting System, maintained by the US Health Care Finance Administration, and that performed laboratory testing during 1996. MAIN OUTCOME MEASURE: Laboratory testing distribution for 1996 in the United States by analyte, method, and specimen type. RESULTS: An overall response rate of 79% provided data from 757 moderate- or high-complexity laboratories and 1322 waived or provider-performed microscopy laboratories. The estimated total US testing volume for 1996 was 7.25 +/- 1.09 billion tests. Laboratories performing complex testing, defined as greater than 16 method/analyte/specimen type combinations, comprised 16% of the US laboratories by survey site, but performed 80% (95% confidence limits, 43% to 100%) of the testing volume. Glucose analysis was the most frequently performed test. Automated hematology and chemistry analyzers were the most frequently used methods. CONCLUSIONS: A statistically valid, consistent survey of the distribution of US laboratory testing was obtained. Simple analysis of these data by laboratory type and geographic region can provide insights into where laboratory testing is performed. The study design allows extensions that will facilitate collection of additional data of importance to public health and medical care delivery.

Clinical Laboratory Techniques↗
PubMed2002

Situation analysis of occupational and environmental health laboratory accreditation in Thailand.

The objective of this study was to analyze the current situation of laboratory accreditation (LA) in Thailand, especially on occupational and environmental health. The study integrated both quantitative and qualitative approaches. The response rate of the quantitative questionnaires was 54.5% (226/415). The majority of the responders was environmental laboratories located outside hospital and did not have proficiency testing. The majority used ISO 9000, ISO/IEC 17025 or ISO/ EEC Guide 25, and hospital accreditation (HA) as their quality system. However, only 30 laboratories were currently accredited by one of these systems. Qualitative research revealed that international standard for laboratory accreditation for both testing laboratory and calibration laboratory was ISO/IEC Guide 25, which has been currently revised to be ISO/IEC 17025. The National Accreditation Council (NAC) has authorized 2 organizations as Accreditation Bodies (ABs) for LA: Thai Industrial Standards Institute, Ministry of Industry, and Bureau of Laboratory Quality Standards, Department of Medical Sciences, Ministry of Public Health. Regarding LA in HA, HA considered clinical laboratory as only 1 of 31 items for accreditation. Obtaining HA might satisfy the hospital director and his management team, and hence might actually be one of the obstacles for the hospital to further improve their laboratory quality system and apply for ISO/IEC 17025 which was more technically oriented. On the other hand, HA may be viewed as a good start or even a pre-requisite for laboratories in the hospitals to further improve their quality towards ISO/IEC 17025. Interviewing the director of NAC and some key men in some large laboratories revealed several major problems of Thailand's LA. Both Thai Industrial Standards Institute and Bureau of Laboratory Quality Standards did not yet obtain Mutual Recognition Agreement (MRA) with other international ABs. Several governmental bodies had their own standards and accreditation systems, and did not accept other bodies' standards and systems. This put a burden to private laboratories because they had to apply and get accredited from several governmental bodies, but still had to apply and get accredited from international ABs especially for those dealing with exports. There were only few calibration laboratories, not enough for supporting the calibration required for the equipment in testing laboratories' LA. Purchasing proficiency testing specimens from abroad was very expensive, and often got into troubles with the customs duty procedures. The authors recommend some strategies and activities to improve laboratory accreditation in Thailand. Improvement in occupational and environmental health laboratories would essentially be beneficial to laboratory accreditation of other areas such as clinical laboratory.

Accreditation↗
PubMed1999

Quality assurance in molecular genetic testing laboratories.

CONTEXT: Specific regulation of laboratories performing molecular genetic tests may be needed to ensure standards and quality assurance (QA) and safeguard patient rights to informed consent and confidentiality. However, comprehensive analysis of current practices of such laboratories, important for assessing the need for regulation and its impact on access to testing, has not been conducted. OBJECTIVE: To collect and analyze data regarding availability of clinical molecular genetic testing, including personnel standards and laboratory practices. DESIGN: A mail survey in June 1997 of molecular genetic testing laboratory directors and assignment of a QA score based on responses to genetic testing process items. SETTING: Hospital-based, independent, and research-based molecular genetic testing laboratories in the United States. PARTICIPANTS: Directors of molecular genetic testing laboratories (n = 245; response rate, 74.9%). MAIN OUTCOME MEASURE: Laboratory process QA score, using the American College of Medical Genetics Laboratory Practice Committee standards. RESULTS: The 245 responding laboratories reported availability of testing for 94 disorders. Personnel qualifications varied, although all directors had doctoral degrees. The mean QAscore was 90% (range, 44%-100%) with 36 laboratories (15%) scoring lower than 70%. Higher scores were associated with test menu size of more than 4 tests (P = .01), performance of more than 30 analyses annually (P = .01), director having a PhD vs MD degree (P = .002), director board certification (P = .03), independent (P <.001) and hospital (P = .01) laboratories vs research laboratory, participation in proficiency testing (P<.001), and Clinical Laboratory Improvement Amendment certification (P = .006). Seventy percent of laboratories provided access to genetic counseling, 69% had a confidentiality policy, and 45% required informed consent prior to testing. CONCLUSION: The finding that a number of laboratories had QA scores that may reflect suboptimal laboratory practices suggests that both personnel qualification and laboratory practice standards are most in need of improvement to ensure quality in clinical molecular genetic testing laboratories.

Certification↗
PubMed1998

District, state or regional veterinary diagnostic laboratories.

The district, regional or state laboratory is the local laboratory to which veterinarian practitioners usually submit samples, and consequently these laboratories are usually the first to observe a suspected disease problem. In most countries, these laboratories are under the jurisdiction of the State or region in which they are located. In the United States of America (USA), most veterinary diagnostic laboratories are State-associated and operate under the aegis of either the State Department of Agriculture or a university. The national laboratory provides reference assistance to the State laboratories. In the USA, the national Laboratory (the National Veterinary Services Laboratories) acts as a consultant to confirm difficult diagnoses and administer performance tests for State-associated laboratories. District, state or regional laboratories need to share information regarding technological advances in diagnostic procedures. This need was met in the USA by the formation of the American Association of Veterinary Laboratory Diagnosticians (AAVLD) in the late 1950s. Another requirement of district, state or regional diagnostic laboratories is a method to confirm quality assurance, which was fulfilled in the USA by an accreditation programme established through the AAVLD. The Accreditation Committee evaluates laboratories (on request) in terms of organisation, personnel, physical facilities and equipment, records, finance and budget. Those laboratories which meet the standards as established in the 'Essential Requirements for Accreditation' are given accreditation status, which indicates that they have the expertise and facilities to perform tests on food-producing animals for shipment in national or international commerce and on companion, laboratory or zoo animals. While confidentiality of test records is most important, it is becoming necessary to release certain types of animal disease test information if a country is to participate in the exportation of animals and animal products. As district, state and regional laboratories operate under many different administrative entities (i.e., universities, State governments and the Federal government), various checks at different administrative levels provide safeguards and reduce the possibility of faulty disease reporting.

Accreditation↗
PubMed2002

Lack of standardization in performance of the semen analysis among laboratories in the United States.

OBJECTIVE: To determine the level of standardization in performance of the semen analysis among clinical laboratories in the United States. DESIGN: A survey was mailed to laboratories requesting information about the laboratory and performance of the semen analysis. Responses were received from 536 laboratories. SETTING: Clinical laboratories enrolled in the American Association of Bioanalysts Andrology Proficiency Testing Program. PATIENT(S): None. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Agreement among laboratories. RESULT(S): Sixty-one percent of respondent laboratories were part of an assisted reproductive technology program. The laboratories perform less than 50 (53%), less than 10 (25%), or less than 5 (16%) andrology laboratory procedures per month. The laboratories routinely report sperm count (94% of laboratories), motility (95%), morphology (85%) and forward progression (69%), and semen volume (96%) as part of the semen analysis. Only 64% of laboratories routinely report abstinence, and 60% of laboratories indicate the criteria used for sperm morphology on the report form. The most common lower limits of normality for sperm count and motility were >20 x 10(6)/mL (77% of laboratories) and >50% (59% of laboratories), respectively. Few laboratories performed quality control for sperm counts (29%), motility (41%), and morphology (41%). CONCLUSION(S): These data indicate a significant lack of standardization in the performance and reporting of semen analyses among laboratories in the United States.

Humans↗
PubMed2003

Interlaboratory comparison of extraction efficiency of pesticides from surface and laboratory water using solid-phase extraction disks.

A continuation of an earlier interlaboratory comparison was conducted (1) to assess solid-phase extraction (SPE) using Empore disks to extract atrazine, bromacil, metolachlor, and chlorpyrifos from various water sources accompanied by different sample shipping and quantitative techniques and (2) to compare quantitative results of individual laboratories with results of one common laboratory. Three replicates of a composite surface water (SW) sample were fortified with the analytes along with three replicates of deionized water (DW). A nonfortified DW sample and a nonfortified SW sample were also extracted. All samples were extracted using Empore C(18) disks. After extraction, part of the samples were eluted and analyzed in-house. Duplicate samples were evaporated in a 2-mL vial, shipped dry to a central laboratory (SDC), redissolved, and analyzed. Overall, samples analyzed in-house had higher recoveries than SDC samples. Laboratory x analysis type and laboratory x water source interactions were significant for all four compounds. Seven laboratories participated in this interlaboratory comparison program. No differences in atrazine recoveries were observed from in-house samples analyzed by laboratories A, B, D, and G compared with the recovery of SDC samples. In-house atrazine recoveries from laboratories C and F were higher when compared with recovery from SDC samples. However, laboratory E had lower recoveries from in-house samples compared with SDC samples. For each laboratory, lower recoveries were observed for chlorpyrifos from the SDC samples compared with samples analyzed in-house. Bromacil recovery was <65% at two of the seven laboratories in the study. Bromacil recoveries for the remaining laboratories were >75%. Three laboratories showed no differences in metolachlor recovery; two laboratories had higher recoveries for samples analyzed in-house, and two other laboratories showed higher metolachlor recovery for SDC samples. Laboratory G had a higher recovery in SW for all four compounds compared with DW. Other laboratories that had significant differences in pesticide recovery between the two water sources showed higher recovery in DW than in the SW regardless of the compound. In comparison to earlier work, recovery of these compounds using SPE disks as a temporary storage matrix may be more effective than shipping dried samples in a vial. Problems with analytes such as chlorpyrifos are unavoidable, and it should not be assumed that an extraction procedure using SPE disks will be adequate for all compounds and transferrable across all chromatographic conditions.

Acetamides↗
PubMed2004

Within- and between-laboratory precision in the measurement of body volume using air displacement plethysmography and its effect on body composition assessment.

OBJECTIVE: To determine and compare the extent of within- and between-laboratory precision in body volume (BV) measurements using air displacement plethysmography (ADP), the BOD POD body composition system, and to interpret any such variability in terms of body composition estimates. DESIGN: Repeated test procedures of BV assessment using the BOD POD ADP were reproduced at two laboratories for the estimation of precision, both within and between laboratories. SUBJECTS: In total, 30 healthy adult volunteers, 14 men (age, 19-48 y; body mass index (BMI), 19.7-30.3 kg/m2) and 16 women (age, 19-40 y; BMI, 16.3-35.7 kg/m2), were each subjected to two test procedures at both laboratories. Two additional volunteers were independently subjected to 10 repeated test procedures at both laboratories. MEASUREMENTS: Repeated measurements of BV, uncorrected for the effects of isothermal air in the lungs and the surface area artifact, were obtained using the BOD POD ADP, with the identical protocol being faithfully applied at both laboratories. Uncorrected BV measurements were adjusted to give estimates of actual BV that were used to calculate body density (body weight (BWt)/actual BV) from which estimates of body composition were derived. The differences between repeated BV measurements or body composition estimates were used to assess within-laboratory precision (repeatability), as standard deviation (SD) and coefficient of variation; the differences between measurements reproduced at each laboratory were used to determine between-laboratory precision (reproducibility), as bias and 95% limits of agreement (from SD of the differences between laboratories). RESULTS: The extent of within-laboratory methodological precision for BV (uncorrected and actual) was variable according to subject, sample group and laboratory conditions (range of SD, 0.04-0.13 l), and was mostly due to within-individual biological variability (typically 78-99%) rather than to technical imprecision. There was a significant (P<0.05) bias between laboratories for the 10 repeats on the two independent subjects (up to 0.29 l). Although no significant bias (P=0.077) was evident for the sample group of 30 volunteers (-0.05 l), the 95% limits of agreement were considerable (-0.68 to 0.58 l). The effects of this variability in BV on body composition were relatively greater: for example, within-laboratory precision (SD) for body fat as % BWt was between 0.56 and 1.34% depending on the subject and laboratory; the bias (-0.59%) was not significant between laboratories, but there were large 95% limits of agreement (-3.67 to 2.50%). CONCLUSION: Within-laboratory precision for each BOD POD instrument was reasonably good, but was variable according to the prevailing conditions. Although the bias between the two instruments was not significant for the BV measurements, implying that they can be used interchangeably for groups of similar subjects, the relatively large 95% limits of agreement indicate that greater consideration may be needed for assessing individuals with different ADP instruments. Therefore, use of a single ADP instrument is apparently preferable when assessing individuals on a longitudinal basis.

Adult↗
PubMed1990

Cost analysis in the toxicology laboratory.

The process of determining laboratory sectional and departmental costs and test costs for instrument-generated and manually generated reportable results for toxicology laboratories has been outlined in this article. It is hoped that the basic principles outlined in the preceding text will clarify and elucidate one of the most important areas needed for laboratory fiscal integrity and its survival in these difficult times for health care providers. The following general principles derived from this article are helpful aids for managers of toxicology laboratories. 1. To manage a cost-effective, efficient toxicology laboratory, several factors must be considered: the laboratory's instrument configuration, test turnaround time needs, the test menu offered, the analytic methods used, the cost of labor based on time expended and the experience and educational level of the staff, and logistics that determine specimen delivery time and costs. 2. There is a wide variation in costs for toxicologic methods, which requires that an analysis of capital (equipment) purchase and operational (test performance) costs be performed to avoid waste, purchase wisely, and determine which tests consume the majority of the laboratory's resources. 3. Toxicologic analysis is composed of many complex steps. Each step must be individually cost-accounted. Screening test results must be confirmed, and the cost for both steps must be included in the cost per reportable result. 4. Total costs will vary in the same laboratory and between laboratories based on differences in salaries paid to technical staff, differences in reagent/supply costs, the number of technical staff needed to operate the analyzer or perform the method, and the inefficient use of highly paid staff to operate the analyzer or perform the method. 5. Since direct test costs vary directly with the type and number of analyzers or methods and are dependent on the operational mode designed by the manufacturer, laboratory managers should construct an actual test-cost data base for instrument or method in use to accurately compare costs using the "bottom-up" approach. 6. Laboratory expenses can be examined from three perspectives: total laboratory, laboratory section, and subsection workstation. The objective is to track all laboratory expenses through each of these levels. 7. In the final analysis, a portion of total laboratory expenses must be allocated to each unit of laboratory output--the billable procedure or, in laboratories where tests are not billed, the tests produced.(ABSTRACT TRUNCATED AT 400 WORDS)

Costs and Cost Analysis↗
PubMed1995

Automated approaches to rapid-response testing. A comparative evaluation of point-of-care and centralized laboratory testing.

This study evaluates the premise that point-of-care or near-patient testing provides more effective medical care because laboratory turnaround time is reduced and, therefore, presumably the time before therapy begins is reduced. An accurate evaluation of this premise must compare the operation of a point-of-care laboratory and an alternative dedicated, centralized laboratory. Assessment of both laboratory operations with respect to turnaround time, costs and benefits, regulatory factors, and finally patient care outcome are all essential in reaching a conclusion. In this study, laboratory operations in a centralized urgent care laboratory were compared with those of a point-of-care satellite laboratory. Turn-around time analysis for whole blood (heparinized specimens requiring no centrifugation) and serum analytes were measured during a representative time period. Analysis of turnaround time considered both the preanalytic time, defined as collection to receipt of the specimen in the laboratory, and the analytic time component that accounts for receipt, processing, analysis, and reporting of the final data into the laboratory information system. The preanalytic component of the point-of-care satellite laboratory was also compared with the urgent care laboratory equipped with a rapid-transport specimen system. Turnaround time in the point-of-care satellite laboratory and urgent care laboratory equipped with a rapid-transport specimen system. Turnaround time in the point-of-care satellite laboratory and urgent care laboratory equipped with a rapid-transport system were comparable. In this analysis, staff requirements, ability to comply with regulatory requirement, and the increasing demand for a larger selection of tests needed urgently were considered. In a tertiary care medical center, such as the authors', a dedicated, centralized laboratory equipped with a rapid-transport specimen system provides better comprehensive laboratory service than does a point-of-care facility with limited capability.

Automation↗
PubMed1996

Disparities in clinical laboratory performance for blood lead analysis.

OBJECTIVE: To evaluate the validity of blood lead analysis for clinical specimens. DESIGN: We submitted blood lead samples with a known lead concentration, in a blinded fashion, as clinical specimens to 18 laboratories. These laboratories were surveyed for the following characteristics that were hypothesized to be related to assay validity: laboratory ownership (state vs private), participation in the Centers for Disease Control Blood Lead Proficiency Program, assay method, and price. Each laboratory received 6 specimens with an actual blood lead (ABPb) concentration of 0.43 mumol/L (9 micrograms/dL) and 3 additional specimens--each with an ABPb concentration of 0.33, 0.89, and 1.59 mumol/L (6.9, 18.4, and 32.9 micrograms/dL, respectively). OUTCOME MEASURES: Misclassification error rates for reporting an elevation ( > or = 0.48 mumol/L [ > or = 10 micrograms/dL) in the blood lead concentration, the within-laboratory mean and coefficient of variation (CV) (for multiple specimens with an ABPb concentration of 0.43 mumol/L [9 micrograms/dL]), and the adjusted odds of a reported blood lead concentration differing from those of an ABPb concentration by more than 0.14 mumol/L (3 micrograms/dL). RESULTS: Blood lead results were obtained for 157 of 162 submissions. One laboratory reported all blood lead specimens as "below 0.48 mumol/L (10 micrograms/dL)." Two (11%) of 18 specimens with an ABPb concentration of 0.89 mumol/L (18.4 micrograms/dL) and 1 (6%) of 17 with an ABPb concentration of 1.59 mumol/L (32.9 micrograms/dL) were classified as below 0.48 mumol/L (10 micrograms/dL); 2 (11%) of 18 with an ABPb concentration of 0.33 mumol/L (6.9 micrograms/dL) and 44 (42%) of 104 with an ABPb concentration of 0.43 mumol/L (9 micrograms/dL) were classified as 0.48 mumol/L or greater ( > or = 10 micrograms/dL). For specimens with an ABPb concentration of 0.43 mumol/L (9 micrograms/dL), the within-laboratory mean ranged from 0.23 to 0.52 mumol/L (4.8-10.7 micrograms/dL); the CV ranged from 3% to 37%. Laboratories that used anodic stripping voltammetry were 6.3 (95% confidence interval, 1.4-28.6) times more likely to report a specimen that differed from the ABPb concentration by more than 0.14 mumol/L (3 micrograms/dL) than those that used atomic absorption methods. No other laboratory characteristic predicted discordance between the reported blood lead and ABPb concentrations. CONCLUSIONS: This study documents wide variation in the validity of the blood lead measurement among clinical laboratories. While the performance of some laboratories far exceeded the criteria of the Centers for Disease Control Blood Lead Proficiency Program, others made large errors that could have resulted in the false-negative misclassification of children with significant lead exposure. Given these differences, the purchasers of laboratory services may require access to laboratory proficiency data to make rational choices among clinical laboratories. Further study of laboratory performance on clinical specimens is required to determine if order-of-magnitude errors occur with sufficient frequency to warrant routine submission of blinded quality control specimens by proficiency programs and to determine the cause of the poor performance of laboratories that used the anodic stripping voltammetry methodology.

Clinical Laboratory Techniques↗
PubMed1997

Duplex ultrasound criteria for the identification of carotid stenosis should be laboratory specific.

BACKGROUND AND PURPOSE: Published criteria for the determination of carotid stenosis have been widely applied by vascular laboratories. We compared two vascular laboratories and their duplex ultrasound (DU) machines in terms of their overall diagnostic performance and the optimal criteria to identify patients who have a 70% to 99% stenosis of the internal carotid artery. METHODS: Measurements of stenosis by DU and angiography were compared for 123 carotid arteries (60 arteries, laboratory A; 63 arteries, laboratory B). Receiver operating characteristic (ROC) curves were created, and the areas under the ROC curves and the optimal criteria for determining a 70% to 99% stenosis were compared. Multiple regression analysis was used to measure the effect of laboratory on the relationship between angiographic stenosis and DU velocity parameters. RESULTS: Areas under the ROC curves were similar for both laboratories (0.89 to 0.90, laboratory A; 0.90 to 0.92, laboratory B). However, the optimal criterion for the identification of a 70% to 99% carotid stenosis was different for each laboratory. For most velocity parameters, based on regression analyses, the predicted percent angiographic stenosis for laboratory A was significantly greater than that for laboratory B. In addition, performance differed between the laboratories when established criteria from the literature were applied. CONCLUSIONS: Two vascular laboratories with similar diagnostic accuracy by ROC analysis have markedly different "optimal" DU criteria. For a given angiographic stenosis, velocities in one laboratory were consistently greater than those in the other laboratory. Laboratory-specific criteria rather than published criteria should be used to identify patients with internal carotid artery stenoses.

Aged↗
PubMed2006

National survey on the pre-analytical variability in a representative cohort of Italian laboratories.

BACKGROUND: Owing to remarkable advances in automation, laboratory technology and informatics, the pre-analytical phase has become the major source of variability in laboratory testing. The present survey investigated the development of several pre-analytical processes within a representative cohort of Italian clinical laboratories. METHODS: A seven-point questionnaire was designed to investigate the following issues: 1a) the mean outpatient waiting time before check-in and 1b) the mean time from check-in to sample collection; 2) the mean time from sample collection to analysis; 3) the type of specimen collected for clinical chemistry testing; 4) the degree of pre-analytical automation; 5a) the number of samples shipped to other laboratories and 5b) the availability of standardised protocols for transportation; 6) the conditions for specimen storage; and 7) the availability and type of guidelines for management of unsuitable specimens. The questionnaire was administered to 150 laboratory specialists attending the SIMEL (Italian Society of Laboratory Medicine) National Meeting in June 2006. RESULTS: 107 questionnaires (71.3%) were returned. Data analysis revealed a high degree of variability among laboratories for the time required for check-in, outpatient sampling, sample transportation to the referral laboratory and analysis upon the arrival. Only 31% of laboratories have automated some pre-analytical steps. Of the 87% of laboratories that ship specimens to other facilities without sample preparation, 19% have no standardised protocol for transportation. For conventional clinical chemistry testing, 74% of the laboratories use serum evacuated tubes (59% with and 15% without serum separator), whereas the remaining 26% use lithium-heparin evacuated tubes (11% with and 15% without plasma separator). The storage period and conditions for rerun/retest vary widely. Only 63% of laboratories have a codified procedure for the management of unsuitable specimens, which are recognised by visual inspection (69%) or automatic detection (29%). Only 56% of the laboratories have standardised procedures for the management of unsuitable specimens, which vary widely on a local basis. CONCLUSIONS: The survey highlights broad heterogeneity in several pre-analytical processes among Italian laboratories. The lack of reliable guidelines encompassing evidence-based practice is a major problem for the standardisation of this crucial part of the testing process and represents a major challenge for laboratory medicine in the 2000s.

Automation↗
PubMed2006

History and results of the two inter-laboratory round robin endotoxin assay studies on cotton dust.

BACKGROUND: In the US cotton industry, airborne cotton dust levels are regulated, and other countries are moving to specify safety limits for airborne endotoxins. There is concern about potential respiratory health hazards associated with agricultural and other organic dusts. In laboratories, ranking which samples have high and low levels of endotoxin is usually in good agreement between laboratories. When different laboratories assay identical samples, the levels differ. The objective of this research was to evaluate the intra- and inter-laboratory variability for 13 laboratories measuring endotoxin in cotton dust. METHOD: Two inter-laboratory round robin endotoxin assay studies were conducted using cotton dust. In the first round robin, each laboratory used their normal in-house assay method and then used a common extraction protocol. In the second round robin, a common extraction protocol and endotoxin assay kit was used. RESULTS: The intra-laboratory results had small variations but inter-laboratory results had very high variations. The inter-laboratory results using a common extraction protocol showed reduced differences. Using the same extraction protocol and endotoxin assay kit, the intra-laboratory variation was small and inter-laboratory variation was reduced but not enough for inter-laboratory agreement. Most of the laboratories were able to discern between the high and low endotoxin concentration dusts. CONCLUSIONS: Standardization has reduced the differences in results between laboratories and possibly further standardization may bring closer inter-laboratory agreement.

Air Microbiology↗