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PubMed1994

Quantification of medical and operational factors determining central versus satellite laboratory testing of blood gases.

Blood gas measurements performed at the central laboratory and at a satellite laboratory of Brigham and Women's Hospital were studied to determine the differences in quality, turnaround time (TAT), and cost. The quality in both laboratories, as determined by results on proficiency and quality control samples, satisfactorily met current standards for patient care. The central laboratory receives specimens for blood gas measurements through a pneumatic tube system and broadcasts results to computer terminals at the originating site, with a mean TAT of 6 minutes. The satellite laboratory, which is within the neonatal intensive care unit that it serves, has a mean TAT of 4.5 minutes. The difference is attributable to transit time in the pneumatic tube and accessioning time in the central laboratory. The total cost per reportable result was substantially higher for the satellite laboratory than for the central laboratory. The minor difference in TAT can be considered in a cost-benefit analysis that weighs medical utility criteria against cost.

Blood Gas Analysis↗
PubMed1989

Evaluation of stat and routine turnaround times as a component of laboratory quality.

Quality assurance has been an essential part of clinical laboratory operations for more than two decades. Analytic precision and accuracy goals have been established, and laboratory performance is monitored periodically. For a laboratory test to be useful, it must be available in a timely manner. Expedience of result reporting has not, however, been routinely included among measures of laboratory quality. The authors evaluated stat and routine turnaround times for 42,414 requests on 24 clinical analytes over a 14-day period with the use of a personal computer. Median turnaround time is 1.70 times faster for stat than for routine tests. When examined by shift, average turnaround time is considerably faster for tests ordered stat than for tests ordered routinely during the day and evening shifts, when the work load is the greatest. The authors are now examining turnaround time as an indicator of quality laboratory performance and efficiency. Computer systems in many clinical laboratories already have the sophistication necessary to perform turnaround time analysis. The authors recommend that clinical laboratories begin to include timeliness of stat and routine result reporting as part of their quality assurance programs. Laboratories may also wish to investigate the usefulness of stat requests during slower shifts because these requests may interrupt the normal flow of specimens without expediting result reporting.

Laboratories↗
PubMed2002

Accuracy and repeatability of weighing for occupational hygiene measurements: results from an inter-laboratory comparison.

Gravimetric analysis is a fundamental technique frequently used in occupational hygiene assessments, but few studies have investigated its repeatability and reproducibility. Four inter-laboratory comparisons are discussed in this paper. The first involved 32 laboratories weighing 25 mm diameter glassfibre filters, the second involved 11 laboratories weighing 25 mm diameter PVC filters and the third involved eight laboratories weighing plastic IOM heads with 25 mm diameter glassfibre filters. Data from the third study found that measurements using this type of IOM head were unreliable. A fourth study, to ascertain if laboratories could improve their performance, involved a selected sub-group of 10 laboratories from the first exercise that analysed the 25 mm diameter glassfibre filters. The studies tested the analytical measurement process and not just the variation in weighings obtained on blank filters, as previous studies have done. Graphs of data from the first and second exercises suggest that a power curve relationship exists between reproducibility and loading and repeatability and loading. The relationship for reproducibility in the first study followed the equation log s(R) = -0.62 log m + 0.86 and in the second study log s(R) = -0.64 log m + 0.57, where s(R) is the reproducibility in terms of per cent relative standard deviation (%RSD) and m is the weight of loading in milligrams. The equation for glassfibre filters from the first exercise suggested that at a measurement of 0.4 mg (about a tenth of the United Kingdom legislative definition of a hazardous substance for a respirable dust for an 8 h sample), the measurement reproducibility is more than +/-25% (2sigma). The results from PVC filters had better repeatability estimates than the glassfibre filters, but overall they had similar estimates of reproducibility. An improvement in both the reproducibility and repeatability for glassfibre filters was observed in the fourth study. This improvement reduced the reproducibility RSD at the lowest loading of 0.1 mg from 30 to 18%. Sub-groups of data from the better performing laboratories in the first glassfibre filter study produced similar curves to the robust data from the fourth study. These data are useful in estimating the likely accuracy of measurements from a laboratory where good analytical practices exist.

Air Pollutants, Occupational↗
PubMed2001

Mechanism and epidemiology of laboratory animal allergy.

Laboratory animal allergy (LAA) is a form of occupational allergic disease. The development of laboratory animal allergy is due to the presence of IgE antibodies directed against animal proteins. The process of sensitization (development of IgE antibodies) is a complex process which involves interaction of antigen presenting cells and lymphocytes of the Th-2 cell type. These cells generate a host of cytokines and other factors which lead to immediate hypersensitivity reactions and other factors which lead to immediate hypersensitivity reactions and the generation of allergic inflammation. Typical symptoms of laboratory animal allergy include nasal symptoms, such as sneezing, watery discharge, and congestion. Skin rashes are also common. Asthma, which produces symptoms of cough, wheezing, and shortness of breath, may affect 20-38% of workers who are sensitized to laboratory animal allergens. Rarely a generalized, life-threatening allergic reaction (anaphylaxis) may occur. The estimated prevalence of laboratory animal allergy is variable depending on the method used for diagnosis, but nonetheless may affect up to 46% of exposed workers. The presence of pre-existing allergies to non-work place allergens (e.g., dust mite, pollens, molds), exposure to laboratory animal allergens, and possibly tobacco smoking are risk factors for the development of laboratory animal allergy. Progress in the understanding of the mechanism and epidemiology of laboratory animal allergy will lead to improved methods for its prevention.

Animal Technicians↗
PubMed2005

An administrative intervention to improve the utilization of laboratory tests within a university hospital.

BACKGROUND: Improving the appropriateness of testing behavior and reducing the number of laboratory tests have been recognized as essential parts of quality improvement. OBJECTIVE: To assess the effectiveness of an administrative and a short-term educational intervention aimed at reducing clinical biochemistry laboratory utilization. DESIGN: An analysis comparing utilization of laboratory tests performed on in-patients before and after the intervention. SETTING: Computerized database of all laboratory tests performed in Hadassah Ein Kerem Medical Center, Jerusalem, Israel during 1999-2003. INTERVENTION: The administrative intervention included restricting available emergency laboratory tests and frequency of repeated orders. The educational measures included: discussion of the misuse of laboratory tests and its consequences with the hospital medical staff, and presentation of the new restrictive policy. A feedback of the intervention's results was sent to the wards and reviewed with senior medical staff. MAIN OUTCOME MEASURES: Change in utilization (measured as rates per 100 hospital days) of clinical biochemistry tests by hospital division and by selected laboratory tests. RESULTS: An overall reduction of 19% in laboratory tests (95% CI: 18.8-19.2%) was observed in the year after the intervention. Utilization decreased significantly in all the hospital's medical divisions, within a range of 14.9-43.8%. During the intervention period, utilization of hematology tests was reduced by 7.6% (P = 0.009). Statistically significant reductions were noted in the ordering of all 12 selected clinical biochemistry tests. Although the orders of total cholesterol decreased by 72.2%, the utilization of 'high-volume' tests, such as glucose and electrolytes, showed only a modest decrease (7.9% and 6.9%, respectively). CONCLUSIONS: The present study included all hospital medical staff and covered all the available clinical biochemistry tests. This rather simple and low-cost intervention resulted in significant reductions in clinical biochemistry test orders as well as in the ordering of hematological blood tests.

Adult↗
PubMed1988

Effect of laboratory error on the identification of persons with hypercholesterolemia in an employee health service.

Cholesterol is a major risk factor for coronary heart disease. Of 117 employees seen consecutively in the Tennessee State Employee Health Service voluntary screening program, 86 (74%) had cholesterol levels above the reference range reported by a commercial clinical laboratory. This was three times greater than the calculated expected number of 29 (25%, 17 at moderate risk, 12 at high risk for coronary disease). Age and sex adjustment using Lipid Research Clinic guidelines reduced the number with elevated cholesterol to 55 (47%, 24 at moderate risk, 31 at high risk). Split sample cholesterol assays run independently by the commercial laboratory and a university laboratory showed excellent correlation (r = 0.99, commercial laboratory = 1.0 (university laboratory) + 10.8), but a systematic difference of 12.4 mg/dL (SD = 6.4 mg/dL, paired-t = 9.63, p less than 0.00001) between the two laboratories. Further adjustment for this difference reduced the number with elevated cholesterol to 41 (36%, 26 at moderate risk, 15 at high risk). This experience illustrates how small systematic laboratory errors in cholesterol determination can greatly exaggerate the number of persons reported to have clinically important cholesterol elevations. Clinical laboratories should report age and sex adjusted cholesterol reference ranges and provide clients periodic quality assurance reports that their measurements of cholesterol levels are accurate.

Adult↗
PubMed1996

Evaluation of complete blood count results from a new, on-site hemocytometer compared with a laboratory-based hemocytometer.

OBJECTIVE: To compare point-of-care results obtained from an on-site hemocytometer with values provided by an institutional laboratory instrument. DESIGN: A prospective laboratory evaluation. SETTING: The central laboratory and cardiac surgical intensive care unit of a university-affiliated tertiary care center. PATIENTS: Normal range comparison was performed using blood specimens routinely obtained from 48 hospitalized patients for complete blood count analysis. The second evaluation was performed on blood specimens routinely obtained (in the intensive care unit) after cardiac surgery involving extracorporeal circulation in a series of 187 consecutive patients. MEASUREMENTS AND MAIN RESULTS: Hemoglobin concentration, platelet count, mean corpuscular volume, mean platelet volume, and red and white blood cell counts were measured with both on-site (MD 16, Coulter Electronics, Hialeah, FL) and laboratory (STKS, Coulter Electronics) instruments. Hematocrit and red cell distribution width were calculated using measured variables. Blood specimens were obtained from two distinct patients series. To evaluate measurement values within the normal range, a series of 48 routinely obtained blood specimens for complete blood count analysis in our institutional laboratory were utilized for concurrent analysis with the on-site hemocytometer. To evaluate measurement values out of the normal range, a second comparison involved measurements performed on blood specimens obtained in the cardiac surgical intensive care unit for complete blood count analysis. Linear regression demonstrated good correlations between on-site and laboratory hemoglobin concentration (r2 = .97), hematocrit (r2 = .95), platelet count (r2 = .97), mean corpuscular volume (r2 = .91), red cell distribution width (r2 = .80), and red (r2 = .95) and white (r2 = .96) blood cell count results. A marginal correlation was observed between mean platelet volume values (r2 = .47). Bias analysis (mean +/- 2 SD) demonstrated similar measurements between on-site and laboratory hemoglobin concentration, hematocrit, platelet count, red blood cell count, white blood cell count, mean platelet volume, mean corpuscular volume, and red cell distribution width. CONCLUSIONS: On-site hemoglobin concentration, hematocrit, white blood cell count, red blood cell count, red cell distribution width, and platelet count values compare well with those results obtained from the laboratory. The MD 16 hemocytometer (Coulter Electronics) provides on-site hematologic results that can provide an accurate and rapid quantitative assessment of platelets, and red and white blood cells. Rapid access to information obtained from this type of system may be clinically useful, especially in critically ill patients.

Erythrocyte Count↗
PubMedDate not supplied

A review and analysis of the clinical laboratory improvement amendment of 1988: compliance plans and enforcement policy.

In 1988, Congress passed the Clinical Laboratory Improvement Amendment (CLIA), thereby extending coverage of the Clinical Laboratory Improvement Act of 1967 to include quality standards for all laboratory-based testing. The CLIA was enacted to ensure the accuracy, reliability, and timeliness of patient test results, regardless of the location where the tests were performed. This article assessed trends in the enforcement policy of the CLIA through an examination of the Laboratory Registry, an annual publication of those individuals or entities that have had sanctions imposed on them by the Centers for Medicare and Medicaid Services. We reviewed the CLIA, including its oversight, regulations that were promulgated based on it, and its enforcement procedures. We obtained the Laboratory Registries for 1993-2001. Sanctions were categorized into groups per the enforcement regulations (42 C.F.R. section sign 493.2 2000). The data indicated an increasing use of more lenient sanctions from 1997 to 2001, and a gradual increase in fraudulent activity for that same period. One possible explanation for this finding is that implementation of compliance plans by participating clinical laboratories had a mitigating effect on enforcement policy. Compliance plan guidance from the OIG provides an opportunity for laboratory service providers to be proactive in their attempts to decrease errors, and thus improve accuracy and reliability by documenting laboratory policies, procedures, and objectives.

Accreditation↗
PubMed1997

Impact of improved laboratory compliance on notification of genital Chlamydia trachomatis infection in Victoria.

BACKGROUND AND OBJECTIVES: Although regulations in Victoria require notification of chlamydia infection by both clinician and laboratory, review found many reports that were notified only by one source (i.e., were unmatched). GOALS: To identify problems with the notification system and to improve the quality of surveillance for this disease. STUDY DESIGN: All notified cases of chlamydia diagnosed in January or February 1995 were followed up by contacting diagnosing doctors. Identified noncompliant laboratories were asked to provide a list of all diagnoses for the period and institute ongoing reporting. Notification data were reviewed for timeliness and completeness. RESULTS: Clinicians never notified without laboratory confirmation. Soliciting laboratory reports increased total notifications by 30%, and there was a highly significant improvement in reporting by both clinicians and laboratories. Reasons for failure to notify by clinicians included an assumption by some clinicians that laboratories would notify and ignorance that notification was required. CONCLUSIONS: Notified cases generally are now accompanied by a laboratory report, and although nonnotification by clinicians continues, notification has improved. Further improvements in clinician notification may depend on doctors knowing that public health action results from reporting. An alternative to requiring doctors' time to be spent in duplicate notification would be to strengthen laboratory reporting and then check that adequate treatment and partner notification has occurred through contact with the diagnosing doctor.

Adult↗
PubMed2000

Is clinical pathology accreditation worth it? A survey of CPA-accredited laboratories.

Following two pilot studies, Clinical Pathology Accreditation (CPA) accreditation was introduced to UK pathology laboratories in 1992. Since then, significant numbers of laboratories have undergone accreditation but many have never applied. We carried out a postal survey of 145 accredited laboratories in the UK to independently determine the opinions of laboratory managers/clinicians about CPA and whether accreditation had produced any significant benefits to pathology services. Ninety-three replies were received (64 per cent) a good response to an unsolicited questionnaire. Most laboratories felt accreditation by CPA had resulted in better laboratory performance with more documentation and better health and safety and training procedures. CPA accreditation was believed to provide useful information by approximately 50 per cent of laboratories but was also felt by a significant proportion of laboratories to be over-bureaucratic, inefficient and expensive (46 of 93 respondents). Many complaints were voiced about the excessive paperwork that CPA generated and there was also a significant body of opinion that felt that CPA assessed areas were the domain of other regulatory bodies such as the CPSM, IBMS and HSE.

Accreditation↗
PubMed2005

Laboratory safety monitoring of chronic medications in ambulatory care settings.

OBJECTIVE: To evaluate laboratory safety monitoring in patients taking selected chronic prescription drugs. DESIGN: Retrospective study using 1999-2001 claims data to calculate rates of missed laboratory tests (potential laboratory monitoring errors). Eleven drugs/drug groups and 64 laboratory tests were evaluated. SETTING: Two staff/network model health maintenance organizations. PATIENTS: Continuously enrolled health plan members age> or =19 years taking > or =1 chronic medications. MEASUREMENTS AND MAIN RESULTS: Among patients taking chronic medications (N=29,823 in 1999, N=32,423 in 2000, and N=36,811 in 2001), 47.1% in 1999, 45.0% in 2000, and 44.0% in 2001 did not receive > or =1 test recommended for safety monitoring. Taking into account that patients were sometimes missing more than 1 test for a given drug and that patients were frequently taking multiple drugs, the rate of all potential laboratory monitoring errors was 849/1,000 patients/year in 1999, 810/1,000 patients/year in 2000, and 797/1,000 patients/year in 2001. Rates of potential laboratory monitoring errors varied considerably across individual drugs and laboratory tests. CONCLUSIONS: Lapses in laboratory monitoring of patients taking selected chronic medications were common. Further research is needed to determine whether, and to what extent, this failure to monitor patients is associated with adverse clinical outcomes.

Ambulatory Care↗
PubMed1992

Standardization of sensitive human immunodeficiency virus coculture procedures and establishment of a multicenter quality assurance program for the AIDS Clinical Trials Group. The NIH/NIAID/DAIDS/ACTG Virology Laboratories.

An independent quality assurance program has been established by the Division of AIDS, National Institute of Allergy and Infectious Diseases, for monitoring virologic assays performed by nearly 40 laboratories participating in multicenter clinical trials in the United States. Since virologic endpoints are important in evaluating the timing and efficacy of therapeutic interventions, it is imperative that virologic measurements be accurate and uniform. When the quality assurance program was initially created, fewer than 40% of the laboratories could consistently recover human immunodeficiency virus (HIV) from peripheral blood mononuclear cells (PBMCs) of HIV-infected patients. By comparing coculture procedures in the more competent laboratories with those in laboratories who were struggling to isolate virus, optimal conditions were established and nonessential reagents and practices were eliminated. Changes were rapidly introduced into a laboratory when experience dictated that such modifications would result in a favorable outcome. Isolation of HIV was enhanced by optimizing the numbers and ratios of patient and donor cells used in cultures, by standardizing PBMC separation procedures, by using fresh rather than frozen donor PBMCs, by processing whole blood within 24 h, and by using natural delectinated interleukin 2 instead of recombinant interleukin 2 products in existence at that time. Delays of more than 8 h in the addition of phytohemagglutinin-stimulated donor cells to freshly separated patient PBMCs reduced recovery. Phytohemagglutinin in cocultures and the addition of Polybrene and anti-human alpha interferon to media were not important in HIV isolation. The introduction of a consensus protocol based on this information brought most laboratories quickly into compliance. In addition, monthly monitoring has successfully maintained proficiency among the laboratories, a process that is critical for the scientific integrity of collaborative multicenter trials. Problems which might not be appreciated for months are now being resolved early, before data can be compromised unknowingly. This consensus protocol is recommended for any laboratory attempting to isolate HIV for the purpose of standardizing recovery and for accessing virologic endpoints in clinical trials.

Culture Media↗
PubMed1993

Ability of clinical laboratories to detect antimicrobial agent-resistant enterococci.

To test the ability of clinical laboratories to detect antimicrobial resistance among enterococci, we sent four vancomycin-resistant enterococcal strains and one beta-lactamase-producing enterococcus to all 93 nongovernment, hospital-based clinical laboratories in New Jersey; 76 (82%) participated in the study. Each organism was tested by the laboratory's routine antimicrobial susceptibility testing method. The proportion of laboratories that correctly reported that an isolate was resistant to vancomycin varied according to the resistance level of the isolate: high-level resistance (MIC for Enterococcus faecium = 512 micrograms/ml), 96% of laboratories correct; moderate-level resistance (MIC for E. faecium = 64 micrograms/ml), 27% correct; low-level resistance (MIC for Enterococcus faecalis = 32 micrograms/ml), 16% correct; and intrinsic low-level resistance (MIC for Enterococcus gallinarum = 8 micrograms/ml), 74% correct. The beta-lactamase-producing E. faecalis isolate was identified as resistant to penicillin and ampicillin by 66 and 8% of laboratories, respectively, but only three laboratories recognized that it was a beta-lactamase producer. This survey suggests that many laboratories may fail to detect antimicrobial agent-resistant enterococci.

Ampicillin Resistance↗
PubMed2004

Expertise of French laboratories in detection, genotyping, and quantification of hepatitis C virus RNA in serum.

Before initiating new large-scale therapeutic trials for hepatitis C virus (HCV)-infected patients, the French Health Authorities for HCV research decided to organize an evaluation of the expertise of laboratories that could be engaged to undertake molecular biology assays in such trials; 21 experienced laboratories participated in this national evaluation of laboratory expertise, which was performed in two successive rounds. The first round evaluated the laboratories for their abilities to detect HCV RNA in serum, determine genotypes, and quantify HCV RNA loads. The results observed by qualitative assays for HCV RNA detection were 100% sensitivity and 100% specificity for all laboratories. The genotyping results were 100% concordant for 9 laboratories and greater than 90% for 10 laboratories. By contrast, large coefficients of variation were observed for quantitative determination of HCV RNA loads, leading to a second round with standardized quantitative assays only. The dispersion of the results was larger by the AMPLICOR HCV Monitor assay than by the branched-DNA assay (mean coefficients of variation, 57.4 and 16.9%, respectively). In the majority of cases, discrepancies between the results of the two tests were found for samples with high viral loads. These results indicate the usefulness of validating, by controlling for expertise, both the reliabilities of laboratories involved in multicenter work and the standardized assays chosen for use in the evaluation of the biological impacts of new therapies.

Analysis of Variance↗
PubMed1985

A study of workload units in five microbiology laboratories.

A study of a modified Canadian unit system of measuring laboratory workload was undertaken in five joint Public Health Laboratory Service and hospital microbiology laboratories. Ten percent of the specimens received over six months were sampled, the number of units expended on each was recorded, and the results were analysed on a central computer. The process of gathering information in the absence of laboratory computers was time consuming and, despite careful planning, differences were found in the recording practices of the laboratories. The analysis of results did not lead to major changes in data gathering techniques because the same information about laboratory workload could be obtained by collecting numbers of clearly defined specimens. Analysis of workload units could be useful for particular purposes, such as comparing differences between laboratories using different techniques for the same investigation or assessing the possible benefits of automation. It must be appreciated, however, that workload units are measures of quantity not of laboratory performance.

Blood↗
PubMed2000

Immunohistochemical demonstration of oestrogen and progesterone receptors: correlation of standards achieved on in house tumours with that achieved on external quality assessment material in over 150 laboratories from 26 countries.

AIMS: To investigate the sensitivity of immunohistochemical (IHC) assays for oestrogen receptors (ER) and progesterone receptors (PR) achieved by laboratories on breast tumours fixed and processed in their own department, and to compare this with the degree of sensitivity they achieve on tumours circulated as part of an external quality assessment (EQA) programme. METHODS: On 10 occasions between April 1994 and June 1998, histological sections from breast cancers showing various degrees of expression of ER and PR were circulated for IHC staining to laboratories participating in the UK national external quality assessment scheme for immunocytochemistry (UK NEQAS-ICC). The staining of these tumours, in addition to that of tumours fixed and processed in the participants own laboratories (in house tumours), was assessed by a panel of four assessors, using the established UK NEQAS-ICC scoring system. For a selected assessment run, the degree of expression of participants in house tumours was evaluated by means of the semiquantitative quick score method. RESULTS: Although the scores awarded for the staining of in house tumours were generally higher than those awarded for the staining of UK NEQAS tumours, there was also a significant positive correlation between the two sets of scores. Using the quick score method of evaluation for one of the assessment runs, 47% of in house tumours were classified as having a high degree of ER expression. Of the remaining cases, a significant proportion initially classified as having only low or medium expression of ER were found to have higher expression when stained by the organising laboratory. The UK NEQAS-ICC centre's routine assay for hormonal receptors was found to be 90-100% efficient in achieving optimal demonstration of breast tumours from over 150 different laboratories. CONCLUSIONS: The significant positive correlation between the results obtained on the UK NEQAS tumours and the in house tumours provides evidence for the view that results achieved on EQA material are accurate indicators of in house laboratory performance. Although most laboratories adequately detected tumours with high receptor expression, a large proportion of in house tumours classified initially by participants' staining as being of low or medium ER expression had a higher degree of expression when stained by the UK NEQAS-ICC centre. The efficiency of the organising centre's routine IHC method for ER and PR in optimally demonstrating participants in house breast tumours shows that variations in fixation and tissue preparation are not limiting factors preventing a different laboratory achieving optimal demonstration.

Breast Neoplasms↗
PubMed1991

ACC/AHA guidelines for cardiac catheterization and cardiac catheterization laboratories. American College of Cardiology/American Heart Association Ad Hoc Task Force on Cardiac Catheterization.

It is evident that the practice of cardiac catheterization has undergone, and continues to undergo, marked change. Most prominent are the recent very rapid proliferation of catheterization laboratories in general and the development of newer types of catheterization laboratory. No uniform definitions exist for these newer laboratories, so meaningful communication is difficult. The new settings are of particular concern because their location, mobility, organization, and ownership raise questions about the quality of patient care. Most difficult to address are the questions about patient safety and physician conflict of interest. There are no objective data in peer-reviewed literature to support the reported safety and cost savings of these newer settings. Through deliberations, surveys, interviews, and correspondence with the cardiology community embraced by the ACC and the AHA, the task force generally found that in freestanding catheterization laboratories, access to emergency hospitalization may be delayed, and appropriate oversight may be lacking. Additionally, opportunities for self-referral may be fostered and the perception of commercialism and entrepreneurial excess in practice created. All of these problems must be avoided. The growth and development of some freestanding facilities, particularly the mobile laboratories, do not seem to have been driven by an increased need in remote communities or for temporary support but rather almost exclusively by a desire to capture market share. Accordingly, a series of definitions, guidelines, and recommendations for the laboratories as well as for patient selection has been developed. The consensus was that a very restrictive and cautious attitude to the newer settings is appropriate at this time. The justification for development or expansion of cardiac catheterization services must be patient need. Documentation of this need must be based on objective estimates of the number of patients with known or suspected cardiac disease who meet generally accepted indications for laboratory study. Concerns about the lack of data from prospective clinical trials of patient safety in such a group necessitate a very cautious attitude toward any new catheterization services, in particular those without in-house cardiac surgical support. In view of the lack of appropriately controlled safety and need data for hospital-based, mobile, or freestanding laboratories operating without on-site (accessible by gurney) cardiac surgery facilities, the task force reaffirms the position that further development of these services cannot be endorsed at this time. In addition, there is reason for major concern that such proliferation in catheterization services may contribute to increasing costs and troubling ethical questions.

American Heart Association↗
PubMed2004

The quality assurance of proficiency testing programs for animal disease diagnostic laboratories.

Laboratory data credibility has 3 major components: 1) valid methods, 2) proficiency testing (PT) to verify that the analyst can conduct the method and to compare results of other laboratories using the same method, and 3) third-party accreditation to verify that the laboratory is competent to conduct testing and that the method validation has been done within the environment and requirements of an effective quality-management system. Participation in external PT programs by a laboratory is strongly recommended in International Organization for Standardization/International Electrotechnical Commission International Standard 17025. Most laboratory accreditation bodies using this standard require that laboratories participate in such programs to be accredited. Internal PT is also recommended for each analyst. Benchmarking, or comparison between laboratories using PT or reference materials, is also recommended as part of the validation and evaluation of test methods. These requirements emphasize the need for proficiency test providers to demonstrate their competence. Requirements for competence are documented in national and international standards and guidelines, and accreditation is available for providers. This article discusses the activities and the components that are necessary and recommended for PT projects and programs for animal disease diagnostic testing. These are based on the requirements of the national and international standards, which address this subject, and on the experience of the author. The accreditation of external PT programs is also discussed. Organizations that accredit PT providers or that provide PT programs are listed. Existing references, guidelines, and standards that are relevant to PT in veterinary diagnostic laboratories are discussed.

Accreditation↗