Laboratory compliance with federal government and professional society recommendations

Quality assurance issues have assumed growing importance in the cytology laboratory. The 1988 Clinical Laboratories Improvement Amendment (CLIA '88) (United States Department of Health and Human Services, Federal Register: U.S. Government Printing Office 1990;55:9495) regulates the patient identifiers and clinical data on the requisition form but does not mandate physician compliance to provide the information. We investigated the use of patient identifiers and clinical data by laboratories as specimen acceptance/rejection criteria. We surveyed 81 board certified cytopathologists and 235 randomly selected cytology laboratories for acceptance criteria of cytology specimens and received responses from 104. Approximately two thirds of all responding laboratories had specific criteria for rejecting specimens on the basis of inadequate identification or clinical data. While the vast majority required the specimens to be identified with patient name, collection date, and specimen source, a minority of laboratories required clinical information such as LMP, prior atypical cytologic/histologic specimens, and history of previous therapy. Little correlation was found between practice setting and the use of rejection criteria. Diagn Cytopathol 1994; 11:85–92. © 1994 Wiley-Liss, Inc.     

Inter-laboratory validation of PCR-based detection of Mycobacterium tuberculosis in formalin-fixed, paraffin-embedded tissues

The present study is based on the initiative for quality assurance in pathology of the German Society of Pathology and the Professional Association of German Pathologists. Four panel laboratories with experience and expertise in polymerase chain reaction (PCR) detection of Mycobacterium tuberculosis were selected to establish the prerequisites for continuous external laboratory trials, in particular, by providing pre-tested specimens and evaluation criteria for participating institutes. In the first step, the four panel laboratories performed an internal trial to test their own reliability and reproducibility. Paraffin sections and DNA preparations from 34 tissues (25 clinical specimens and 9 controls) totalling to 66 samples were evaluated by each panel institute according to their own protocols. The methodologies differed and are described in detail. Despite these differences, a high degree of inter-laboratory reliability was achieved. In this report, we summarise our results including the correlation with the histology and provide recommendations for applying PCR-based methodology for the detection of mycobacterial DNA in surgical specimens. Supplementary data are available online at (rubric Forschung). Pre-tested specimens are now available for the external trial and can be ordered from the steering institute via Oligene (). All molecular pathology laboratories are invited to participate in this quality assurance initiative.     

In vitro diagnosis of chronic nasal inflammation

BACKGROUND: Differential diagnosis of chronic nasal inflammation is insufficient when based solely on clinical examination and radiography of paranasal sinuses. Patients complain about more or less similar symptoms. Activation of mast cells and eosinophils is pivotal in nasal inflammation. OBJECTIVE: To compare tryptase and eosinophilic cationic protein (ECP) in nasal secretions in different forms of chronic nasal inflammation and to establish norm values. METHODS: The study included 1710 patients presenting with nasal complaints. Nasal secretions were gained by the cotton wool method and analysed for tryptase, as a marker of mast cell activation, and for ECP, as a marker of tissue eosinophilia and activation. Patients were grouped according to their diagnosis: chronic, non-allergic rhinosinusitis (sinusitis, n=194), non-allergic nasal polyposis (polyposis, n=138), non-allergic rhinitis with eosinophilia syndrome (NARES, n=198), isolated perennial allergic rhinitis (AR) (n=126), isolated seasonal AR (n=132), and patients allergic to both, seasonal and perennial allergens (n=193). Seven hundred and twenty-nine patients with nasal complaints due to a deviated septum and without any nasal inflammation served as controls. RESULTS: Nasal tryptase was highly significantly (P<0.001) elevated in polyposis, NARES, and in AR. ECP was highly significantly (P<0.001) elevated in all groups of patients suffering from chronic nasal inflammation. Based on our data and method we established norm values (95% confidence interval of mean value) for nasal tryptase in healthy adults, ranging from 12.0 to 18.7 ng/mL and for ECP ranging from 84.4 to 102.6 ng/mL. CONCLUSION: Mast cells and eosinophils are involved in non-allergic and allergic forms of chronic nasal inflammation. We established an in vitro assay for tryptase and ECP in nasal secretions and defined norm values based on our data and method. In vitro measurement of biological markers in nasal secretions provides important information for differential diagnosis and therapeutic strategies of chronic nasal inflammation.     

Hemoglobin levels in Tibet: different effect of age and gender for Tibetans vs Han

Tibetans form a population which has resided on the Qinghai–Tibetan plateau for thousands of years, and are reported to have less hemoglobin than Han Chinese lowlanders who have migrated to the plateau. However, for various altitudes, detailed comparisons of hemoglobin in the two ethnic groups has not been reported. We investigated the hypothesis that the effects of altitude, age, and gender on hemoglobin concentration would differ between Han and Tibetan residents of the plateau. Hematological parameters for both genders were determined in healthy Tibetan adults (n=3,000) and children (n=332), and healthy Han Chinese adults (n=2,612) and children (n=275), aged 5–60 years living at four different altitudes (mean altitude of 2,664, 3,813, 4,525, and 5,200 m). Hemoglobin values increased with altitude for all ages in both ethnic groups and in both genders. The gain in hemoglobin with altitude had the rank order: Han males > Han females > Tibetan males and females. Even before puberty, Han children had more hemoglobin than Tibetan children. An effect of age on hemoglobin was seen at the time of puberty in men, but not in women. A positive correlation was found between hemoglobin concentration and age in adult Han males and females, but not in Tibetan males, and only at the higher altitudes, in Tibetan females. In both Tibetans and Hans, males had higher hemoglobin values than females at each altitude, but the gender differences increased with altitude in Han, whereas it either decreased or did not change in Tibetans. Examination of hemoglobin levels by histogram showed non-Gaussian distributions: Tibetan men and women had skewing to higher values, whereas Han men and women had skewing in the opposite direction. We conclude that increasing age and the effect of gender in Tibetans are associated with different hemoglobin responses to altitude than in Han, and we speculate that genetic influences may be involved.     

身心因素与肠易激综合征患者生活质量的相关研究

目的调查肠易激综合征(IBS)患者生活质量状况并评估躯体及心理因素对它的影响。方法采用肠易激综合征生活质量量表(IBS-QOL)、临床症状问卷、艾森克人格问卷简式(EPQ-RSC)、简明心境问卷简式(POMS-SF)、医学应对问卷(MCMQ)对120例IBS患者进行测查,将IBS患者的心理健康水平(人格、情绪、应对)及躯体症状(肠道症状、肠外症状、睡眠障碍)与IBS患者生活质量进行相关分析。结果IBS患者IBS-QOL的8个因子和总分均显著降低(P<0.05),其中健康忧虑和饮食限制降低最为明显,除IBS症状外,肠外症状、睡眠障碍、精神心理异常在IBS患者中也很常见。心理因素中EPQ-RSC神经质(N)分、POMS中焦虑、抑郁等多项因子分及总分、MCMQ屈服积分与IBS-QOL总分呈负相关;躯体因素中IBS症状、肠外症状、睡眠障碍积分与IBS-QOL总分呈负相关。结论肠易激综合征患者的生活质量明显降低,除躯体症状外,心理功能失调也是决定患者生活质量的重要因素。     

Measuring contraceptive values: An alternative approach

Previous assessments of individuals' values for various contraceptive consequences have employed one of four methodologies: free elicitation, direct ratings, multiple regression, or factor analysis. All four methodologies are flawed because they produce group rather than individual values, rely on rating scales, and fail to incorporate information regarding consequence trade-offs. Axiomatic conjoint measurement is proposed as an alternative methodology and used to determine individuals' values for a selected set of contraceptive consequences at two stages of the family-planning career.Preparation of this paper was supported in part by Grants HD-10802 and HD-14403 from the National Institute of Child Health and Human Development. Appreciation is due the Statistical Computing Facility of the University of California at Berkeley. Requests for reprints should be sent to the Publications Librarian, Center for Research on Judgment and Policy, Muenzinger Psychology Building, University of Colorado, Boulder, Colorado 80309-0344.     

癫痫大发作儿童生活质量的研究

应用癫痫患者生活质量量表，以问卷方式，对９１例患儿进行生活质量的研究，并与正常儿童比较及探讨影响因素。结果，患儿生活质量明显低于正常儿童，主要因对发作恐慎、担心长期用药、存在认知障碍及社会交往困难；此外，生活质量与学习成绩也有关。即使发作已被控制，患儿生活质量并无明显改善。因而对患儿除药物治疗外，应加强非药物的心理治疗及提高学习能力，才能提高癫痫患儿的生活质量。     

Chemical,radiochemical, and radionuclide purity of eluates from different commercial fission99Mo/99mTc generators

Seven⁹⁹Mo/^99mTc generators (using fission⁹⁹Mo) obtained from seven different manufactures were studied in 1984 and 1985 to test the quality of the eluates. We present the findings concerning the elution efficiency, radionuclide purity,⁹⁹Mo breakthrough, radiochemical purity, pH, and aluminium content of the eluates. One generator was overloaded with⁹⁹Mo by about 40%, while one generator had^99mTc yields of only about 80%. The eluates generally (although with some exceptions) exhibited a high and satisfactory radionuclidic purity and good radiochemical purity. The low-level determination of⁹⁹Mo break-through using a commercially available dose calibrator with a⁹⁹Mo assay shiled indicated a misleadingly high⁹⁹Mo content. All of the eluates had pH values of between 5.0 and 5.5, and the aluminium content was always below the detection limit of 1 g per milliliter of eluate. The generators performed well and proved their capability of functioning as reliable sources of sodium pertechnetate Tc99m. In all cases, the pertechnetate produced met the requirements of the European Pharmacopeia.This report is based on work conducted within the scope of a research poject devised by the Ministry of the Interior of the Federal Republic of Germany (Hammermaier et al. 1985). The present report reflects the opinions of the authors and does not necessarily express the views of the Federal Ministry of the Interior