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Noise exposure, music, and animals in the laboratory: a commentary based on Laboratory Animal Refinement and Enrichment Forum (LAREF) discussions.

The effects of noise, in general, and music, in particular, on the behavior and welfare of animals in the laboratory deserve a great deal of empirical study. However, many laboratories must develop their current practices on the basis of sparse and conflicting data. With this commentary we seek to establish some of the factors that should be taken into account in deciding how to deal with sources of uncontrolled or deliberate sound and, specifically, in determining whether to play music in the laboratory. Views differ, however, the balance of evidence supports the use of quiet music during nonhuman animals' active periods, if this practice is introduced with an awareness of the risks to welfare and research.

Animal Welfare↗

Laboratory manager's financial handbook. The laboratory's importance to the financial stability of a health-care organization.

From a financial standpoint, one of the most valuable assets in the survival of a health-care organization is the clinical laboratory. Laboratory directors, managers, and supervisors have indicated their overwhelming need to understand finance, especially cost management, to CLMA and to the author at national meetings and workshops, Tremendous financial pressures are being applied in health-care organizations across the country. Two strategic factors in their successful move into the 21st century are more appropriate test utilization and cost control in the laboratory.

Accounting↗

Using patient satisfaction as an indicator of the quality of laboratory services. Applying social science methods to evaluate outcomes in laboratory medicine.

The authors discuss methods of outcomes research using patient satisfaction as a quality indicator for evaluating point-of-care (POC) laboratory methods. After commenting on the rationale for using this approach, we focus on specific techniques for developing questionnaires, collecting survey response data, and building a database for analysis. We also address problems that arise in incorporating data from medical records into a research database and the linkage of records from disparate sources. Approaches to cost analysis are discussed, including problems with the use of financial and billing records. Preliminary results thus far show no significant effects from the use of POC prothrombin time testing on hospital inpatient evaluations of their overall care. Using laboratory charges and total reimbursements for treatment as proxies for cost, we found a significant (p < 0.0001) difference in the costs for POC testing over those for testing in the central laboratory.

Alabama↗

Laboratory costs and utilization: guidelines for efficient use of laboratory technology.

The practice of laboratory medicine now plays a major role in the delivery of health care. Under PPS, however, the laboratory has come under close scrutiny as one place where costs can be reduced. This article examines the use of continuous-flow and discrete analyzers in the chemistry laboratory and provides guidelines for determining which analyzer is most appropriate for a given organization.

Autoanalysis↗

Developing guidelines for allocating catheterization laboratory resources: lessons from an Ontario Consensus Panel. Consensus Panel on Cardiac Catheterization Laboratory Services in Ontario and the Steering Committee of the Cardiac Care Network of Ontario.

In March 1997, the Ontario Ministry of Health asked the Cardiac Care Network of Ontario (CCN) to develop guidelines for allocating cardiac catheterization laboratory resources. A consensus panel of providers and planners used findings from the literature and expert opinion to recommend guidelines for the operation of cardiac catheterization laboratories and criteria to be considered when allocating additional cardiac catheterization laboratory resources. This article summarizes the consensus panel's major findings that may be of value to other jurisdictions, including need identification, clinical practice, system issues, location criteria and cost considerations. The article reflects the advice given to the Ontario Ministry of Health by the CCN and is not an official position paper of the Canadian Cardiovascular Society.

Angioplasty, Balloon, Coronary↗

Redundant thyroid laboratory diagnostic modules in laboratory information system--a way to improve the performance.

In this paper, we introduced an idea of using redundant thyroid laboratory diagnostic modules integrated in laboratory information system. The first module was based on decision tree which was the result of Assistant algorithm applied to thyroid laboratory test results. Instead of improving decision rules, the "second opinion" module was designed based on Spad-S software. Diagnosis obtained with both modules were compared with results before introducing the "second opinion" module. From the first results it was clear that introducing the "second opinion" module decreased the number of misclassified records from the first module. With three or more modules, the final diagnosis could be obtained by voting or more complex procedures.

Algorithms↗

[Hospital infection control in 21st century, the importance of networking with each division and clinical laboratory in the hospital. 1. From the aspect of clinical laboratory division].

Clinical laboratory division plays an important roll for the management of nosocomial infection. Staff from clinical laboratory division including technologist and/or medical doctor can work as a part of infection control team. Since the bacterial surveillance data from clinically isolated strains accumulates in the clinical laboratory division, these staff have a chance to notice outbreak in hospital at first time. While handling information from each strain, we need to feedback these data with additional information for physicians. From June, 2000, a national project started. That was a surveillance program for drag-resistant bacteria. We can compare information from local isolates and nation-wide isolates by this project. Genotypic methods especially pulsed-field gel electrophoresis(PFGE) is suitable for the identification of infection route in the hospital environment. And PFGE analysis for pathogenic strains works effective in our hospital.

Cross Infection↗

Comparison of DNA binding in normal population, general hospital laboratory personnel, and personnel from laboratories studying SLE.

Sera from 18 of 56 individuals working in SLE laboratories bound more than 30 per cent of 0.1 mug of 125-I denatured calf thymus DNA, in an ammonium sulfate precipitation assay. Only two of 58 normal non-laboratory personnel and four of 40 sera from routine hospital laboratory personnel bound more than 30 per cent. Statistical analysis of these results with the Kolmogorov-Smirnov nonparametric test indicated this was a very significant difference (p less than .001). Using native DNA as a test antigen a similar pattern was seen, but it was not as clear cut. Part of this increased reactivity is heat labile. Further studies must be carried out before an adequate interpretation of these findings is possible.

Animals↗

General laboratory safety in the physician office laboratory.

It is the laboratory's legal responsibility to ensure safety in the workplace. However, safety is everyone's responsibility. Knowledge of the various safety regulations from OSHA and CLIA, as well as those required by accreditation organizations, is necessary to minimize risk and avoid serious adverse outcomes to patients and employees. The quality and efficiency of a laboratory is a function of laboratory safety.

Humans↗

The andrology laboratory in an Assisted Reproductive Technologies program. Quality assurance and laboratory methodology.

Assuring the highest possible quality of care to the patient is the first goal of the andrology laboratory. Quality control and quality assurance as they apply to the andrology laboratory are outlined, and special problems in quality control for sperm function assays are addressed. An example of the patient review process is presented. Quality of care also depends on the ability of the laboratory to perform appropriate tests of sperm function that can diagnose sperm defects, predict success or failure of in vitro fertilization, and lead to rational therapies for sperm dysfunctions. Methods for, and diagnostic value of, sperm swim-out, enhanced sperm penetration assays, acrosome reaction assessment, motility analysis of capacitating sperm, and sperm-zona binding assays are reviewed. No single test, other than in vitro fertilization itself, is capable of providing a complete diagnosis or a highly accurate prediction. A battery of sperm function tests, arranged in an algorithm, is presented as a theoretically better approach.

Diagnostic Tests, Routine↗

Laboratory-based surveillance for influenza: role of the Wisconsin State Laboratory of Hygiene.

Influenza poses a significant threat to public health worldwide. In the United States alone, mortality attributed to annual epidemics of influenza is estimated at 36,000 deaths per year. Influenza viruses also cause pandemics, during which the rates of illness and death can be expected to be much higher. In order to optimize prevention and control strategies for influenza, a variety of surveillance activities are carried out year-round internationally, nationally, and at the state level. This article summarizes relevant features of influenza and the surveillance activities carried out at each of these levels to monitor influenza activity. Particular emphasis is given to the state's laboratory-based surveillance network, developed and coordinated by the Wisconsin State Laboratory of Hygiene, that features strong and productive partnerships with private sector clinicians and laboratories and that provides a solid foundation for surveillance directed at other public health threats such as Severe Acute Respiratory Syndrome and bioterrorism.

Humans↗

[Laboratory tests in primary care medicine: "essential laboratory tests" (2). Usefulness of hematological, biochemical and serological tests in diagnosis of new outpatients].

We evaluated diagnostic utility of the hematological, biochemical and serological tests comprised in the "essential laboratory tests" advocated by the Japan Society of Clinical Pathology in 1,026 new patients visiting the outpatient unit of Comprehensive Medicine, National Defense Medical College. Of 750 evaluable patients, 52 showed anemia associated with such conditions as ulcer or cancer of digestive tract, inflammatory disease, or renal failure. Leukocytosis (greater than 9,000/microliters) was found only in 25 of 112 CRP-positive (greater than 0.3 mg/dl) patients, suggesting bacterial infection. Forty-four patients showed hypoproteinemia and/or hypoalbuminemia indicating chronic conditions including liver and inflammatory disease. Elevation of serum creatinine level was found in 4 patients subsequently diagnosed with renal failure, whereas 32 patients demonstrated elevated BUN. After application of the "essential laboratory tests", 97 patients were diagnosed with hyperlipidemia (total cholesterol greater than 230 mg/dl and/or triglyceride greater than 250 mg/dl). Determination of serum enzyme activity was useful not only for the diagnosis of liver dysfunction or biliary tract disease but also for those of hematological malignancies or myogenic disorders; however, in patients with abnormal values of LDH, gamma-GT and ALP, clinical significance was not clarified in 53%, 38% and 59%, respectively. These results indicate that the "essential laboratory tests" are useful in the following aspects of primary care medicine: for (1) estimation of the degree or nature of infection or inflammatory status; (2) classification of anemia and its relation to underlying diseases; (3) evaluation of patient general condition and protein-producible function of liver; (4) evaluation of renal function; (5) ambulatory screening for metabolic diseases such as hyperlipidemia; and (6) diagnosis of liver and biliary tract diseases.

Ambulatory Care↗

Evaluation of clinical laboratory instruments. Part I: Defining laboratory needs.

The purchase of a new laboratory instrument can be an exciting challenge for a laboratory director or supervisor. Those responsible for making purchase recommendations should be objective and thorough. The skill with which they discharge this responsibility may affect laboratory performance and employee morale for several years. This paper explores some of the important considerations in purchasing instruments and suggests an approach to vendors to obtain information needed in making decisions.

Equipment and Supplies↗

Federal regulation of clinical laboratories and the Clinical Laboratory Improvement Amendments of 1988--Part I.

In this first part of a two-part article, we have summarized some of the pertinent features of CLIA 1988 with review of the complexity model, waived testing, personnel standards, proficiency testing and quality control requirements, and patient test management. In addition to a survey of other Federal regulations applicable to clinical laboratories, we have briefly reviewed events subsequent to the publication of the Final Rule in February of 1992, specifically the recommendations of CLIAC and the Technical Corrections published on January 19, 1993. The second part of this paper will discuss sanctions and enforcement; how laboratory inspections are likely to be performed, accreditation of private organizations, state exemptions, cytology and other specialty regulations, and the evolving interaction between CLIAC, FDA, CDC, DHHS, and the regulated laboratory community.

Clinical Medicine↗

Federal regulation of clinical laboratories and the Clinical Laboratory Improvement Amendments of 1988--Part II.

This is the second of two articles summarizing federal regulation of clinical laboratories and reviewing specific aspects of the Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988). This article includes a review of sanctions and enforcement, how laboratory inspections are likely to be performed, accreditation of private organizations, state exemptions, cytology and other specialty regulations, and the evolving implementation of CLIA 1988.

Accreditation↗

Medicare's demonstration of competitive bidding for clinical laboratory services: what it means for clinical laboratories.

The purpose of Medicare's Demonstration of Competitive Bidding for Clinical Laboratory Services is to determine whether competitive bidding can be used to provide quality laboratory services at prices below current Medicare reimbursement rates. Here, we present key features of the preliminary design for the demonstration. The following areas are covered: scope of the demonstration, bidding process, selection of winners, reimbursement, quality, and administration and monitoring. The role of the Health Care Financing Administration's Laboratory Technical Advisory Committee is also described, and the future of competitive bidding in a Medicare managed care environment is evaluated. We close with some brief comments on how to succeed in competitive bidding for Medicare services.

Centers for Medicare and Medicaid Services, U.S.↗

Infection prevention guidelines for cardiac catheterization laboratories. Society for Cardiac Angiography and Interventions Laboratory Performance Standards Committee.

The following guidelines for prevention of catheterization laboratory infections are based on standard precautions for infection prevention in surgical wounds. Specific recommendations for patient preparation include proper methods for hair removal, skin cleaning and draping, antibiotic prophylaxis, wound irrigation and dressing, and sheath removal. Sterile precautions should be more vigorous for cutdown procedures compared to percutaneous. Caps, masks, gowns, and gloves help to protect both the patient and operator. Handwashing is the most important procedure for preventing infections. Maintenance of the catheterization laboratory environment includes appropriate cleaning, limitation of traffic, and maintenance of adequate ventilation. Proper catheterization technique and appropriate use of sterile equipment will decrease the wound infection rate. Protection of personnel may be accomplished by proper gowning and gloving, disposal of contaminated equipment, and care of puncture wounds and lacerations. All personnel should receive vaccination for hepatitis B.

Cardiac Catheterization↗

Rapid detection of group A streptococci: comparative performance by nurses and laboratory technologists in pediatric satellite laboratories using three test kits.

Rapid tests for detecting group A streptococci in throat swabs are often performed outside hospitals or commercial laboratories by individuals with little or no technical training. We compared the abilities of nurses and technologists to perform and interpret three commercial kits (Directigen 1-2-3, ICON Strep A, and Culturette Brand 10-Minute Strep A ID) in three hospital satellite locations (the emergency department, a walk-in emergency clinic, and a general pediatric clinic). When the three tests were compared with culture, the sensitivities of the tests as performed by nurses and technologists, respectively, were 39 versus 44% for Directigen, 55 versus 51% for Culturette, and 72 versus 39% for ICON. A significant difference in sensitivity was found only with ICON tests. This result was largely explained by the tendency of technologists to test moist swabs, while nurses generally processed dry swabs; ICON test sensitivity was significantly greater with dry swabs. The specificities of Directigen and ICON tests performed by nurses and technologists were high (97 to 100%). The difference in the specificities of the Culturette test as determined from results obtained by nurses and technologists (80 versus 98%) was due to the tendency of one nurse to overinterpret the latex agglutination reaction. Analysis of the accuracies of the tests during practice periods compared with the accuracies of the tests during the study periods revealed statistically significant improvement in test performance. We conclude that these tests are specific but not sensitive when performed by nurses and technologists in satellite laboratories. With one exception, nurses and technologists performed the tests with comparable accuracy after brief training periods.

Emergency Service, Hospital↗