Solitary blood cultures: a College of American Pathologists Q-probes study of 132,778 blood culture sets in 333 small hospitals.

OBJECTIVE: To determine the frequency with which solitary blood culture samples were submitted to laboratories serving small hospitals and to ascertain whether certain hospital practices relating to the performance of blood cultures were associated with lower solitary blood culture rates (SBCRs). DESIGN: Participants in the College of American Pathologists Q-Probes laboratory quality improvement program collected data prospectively on the numbers of solitary blood culture sets from adult patients submitted to their laboratories and answered questions about their institutions' practice characteristics relating to the collection of blood culture specimens. SETTING AND PARTICIPANTS: Three hundred thirty-three public and private institutions with a median occupied bed size of 57. Participants were located in the United States (n = 329), Canada (n = 3), and Australia (n = 1). MAIN OUTCOME MEASURE: The solitary blood culture rate was defined as the number of instances in which only 1 blood culture venipuncture was performed on an individual patient during a 24-hour period divided by the total number of blood culture venipunctures that were performed during the study period. RESULTS: Participants submitted data on 132 778 adult patient blood culture sets. The SBCRs were 3.4% or less in the top-performing 10% of participating institutions (90th percentile and above), 12.7% in the midrange of participating institutions (50th percentile), and 42.5% or more in the bottom-performing 10% of participating institutions (10th percentile and below). In half the participating institutions, the SBCRs for inpatients were 8.3% or less and for outpatients, 22% or less. Solitary blood culture rates were lower for institutions in which phlebotomists rather than nonphlebotomists routinely collected blood culture specimens, in which internal policies required drawing at least 2 blood culture sets, in which hospital personnel contacted clinicians when their laboratories received requests for solitary blood culture sets, and in which quality control programs monitored SBCRs routinely. CONCLUSIONS: Hospitals can achieve SBCRs under 5%. Those hospitals with particularly high SBCRs may lower their rates by altering certain institutional practices.

Prognostic factors in breast cancer. College of American Pathologists Consensus Statement 1999.

BACKGROUND: Under the auspices of the College of American Pathologists, a multidisciplinary group of clinicians, pathologists, and statisticians considered prognostic and predictive factors in breast cancer and stratified them into categories reflecting the strength of published evidence. MATERIALS AND METHODS: Factors were ranked according to previously established College of American Pathologists categorical rankings: category I, factors proven to be of prognostic import and useful in clinical patient management; category II, factors that had been extensively studied biologically and clinically, but whose import remains to be validated in statistically robust studies; and category III, all other factors not sufficiently studied to demonstrate their prognostic value. Factors in categories I and II were considered with respect to variations in methods of analysis, interpretation of findings, reporting of data, and statistical evaluation. For each factor, detailed recommendations for improvement were made. Recommendations were based on the following aims: (1) increasing uniformity and completeness of pathologic evaluation of tumor specimens, (2) enhancing the quality of data collected about existing prognostic factors, and (3) improving patient care. RESULTS AND CONCLUSIONS: Factors ranked in category I included TNM staging information, histologic grade, histologic type, mitotic figure counts, and hormone receptor status. Category II factors included c-erbB-2 (Her2-neu), proliferation markers, lymphatic and vascular channel invasion, and p53. Factors in category III included DNA ploidy analysis, microvessel density, epidermal growth factor receptor, transforming growth factor-alpha, bcl-2, pS2, and cathepsin D. This report constitutes a detailed outline of the findings and recommendations of the consensus conference group, organized according to structural guidelines as defined.

Intranets: virtual procedure manuals for the pathology lab.

A novel system exists for replacing standard written operation manuals using a computerized PC-based peer-to-peer network. The system design is based on commonly available hardware and software and utilizes existing equipment to minimize implementation expense. The system is relatively easy to implement and maintain, involves minimal training, and should quickly become a financial asset. In addition, such a system can improve access to laboratory procedure manuals so that resources can be better used on a daily basis.

Quality control of proliferation marker (MIB-1) in image analysis systems utilizing cell culture-based control materials.

Standard controls for quality control of cell growth (proliferation) assays in image analysis systems are not currently available. The authors have developed a system of controls, based on cultured and harvested human cell lines, that can mimic tissue sections. These controls help ensure quality control for the entire cell proliferation analysis process, from the initial cutting of the paraffin block through fixation, immunohistochemical staining, and interactive image analysis. The use of cell line controls is advantageous because of the greater cell population homogeneity and the volume of uniform slides that are obtainable, as opposed to the use of a heterogeneous tissue sample. This system provides an excellent means of evaluating the day-to-day performance of cell proliferation analysis and may also be adapted for use as a method of multi-institutional proficiency testing.

Oncocytic adenocarcinoma of minor salivary gland. An unusual glossal presentation of a minor salivary gland tumor.

A case of an unusual oncocytic variant of minor salivary gland adenocarcinoma presenting in the base of the tongue in a 79 year old male with a remote history of regional radiotherapy is presented. The tumor had a striking morphologic similarity to the more common granular cell tumor, with which it could have been easily confused, leading to significant misdiagnosis. The light microscopic, cytologic, immunohistochemical and electron microscopic features are presented, with a discussion of the differentiating features of this lesion compared to other more common benign and malignant glossal tumors.

Quality control of imprint and tissue section DNA ploidy analysis in image analysis systems utilizing cell culture-based control materials.

Currently, there are no standard controls available for quality control of DNA ploidy assays in image analysis systems. The authors have developed a system of controls based on cultured human cell lines that can mimic tissue sections and touch preparations. This allows for quality control for the entire process for DNA ploidy analysis from the initial cutting of the paraffin block or production of the touch preparation through fixation, staining, and interactive image analysis. The use of cell line controls rather than normal tissue is advantageous because of cell population homogeneity and the volume of uniform slides that are obtainable. This system, while providing an excellent means of controlling day-to-day performance of DNA ploidy analysis, may also be adapted for use as a means of multi-institutional proficiency testing.

Proliferating cell nuclear antigen in the determination of growth rates in acoustic neuromas.

The growth rate of acoustic neuromas is difficult to predict clinically; however, the ability to do so would be of benefit to the clinician for patient prognostication. Laboratory studies utilizing flow cytometry and immunologic methods have been used to investigate growth rates of acoustic neuromas. The purpose of this pilot immunohistochemical study, using proliferating cell unclear antigen (PCNA) on 22 randomly selected vestibular schwannomas, was to compare the growth factors, determined immunohistochemically, with the growth rate in this class of lesions. Proliferating cell nuclear antigen is an antibody against DNA polymerase delta, which is expressed in late G1 through S phase of the cell cycle. The advantage of using PCNA is that standard archival formalin-fixed, paraffin-embedded tissues may be analyzed and that PCNA detect cells in G1 through S phase, allowing S-phase fractions, determined by flow cytometry. Results indicate that PCNA immunohistochemical analysis may potentially offer prognostic information relating to the growth potential of each tumor for individual patients with vestibular schwannomas. Further study with an expanded patient population is planned

HER-2/neu oncogene expression, DNA ploidy and proliferation index in breast cancer.

HER-2/neu gene expression, DNA ploidy and proliferation index were studied in 250 cases of breast cancer. Expression of HER-2/neu was determined by using an antibody to the HER-2/neu receptor. Ki-67 antibody was used to determine the proliferation index of the breast cancers, and the Feulgen method was used to assess DNA amounts in the tumor cells. Histochemical staining was quantitated by image analysis. Of the cancers studied, 72 were positive for overexpression of HER-2/neu protein; of these, 62 (86%) possessed near-tetraploid DNA content, and 47 (65%) had more than one G0G1 stem line (polyploid) of DNA distribution. Cells from the cases negative for HER/2-neu overexpression contained DNA amounts that ranged from diploid to varying degrees of aneuploid. A significant difference in the amounts of cellular proliferation in HER-2/neu overexpressing cancers was found between those that expressed the HER-2/neu receptor on their membranes and those that exhibited mainly cytoplasmic receptors.

HER-2/neu oncogene expression and proliferation in breast cancers.

Amplification of the HER-2/neu proto-oncogene in breast cancer has been reported to correlate with poor patient prognosis. The proliferation, or growth fraction, of cells has also been shown to be of prognostic importance in breast cancer. A study was conducted to evaluate the correlation between HER-2/neu gene expression and proliferation in breast cancer. Quantitative immunohistochemical methods for the detection of the HER-2/neu protein expression and for assessing the proliferation fraction on frozen sections of tumor cells were used. The detection of epidermal growth factor receptor (EGFR) along with quantitative DNA ploidy analysis, also was performed on the same breast cancers. The results indicated two subgroups of invasive ductal carcinoma; 1) HER-2/neu overexpressing cases that were negative for EGFR expression and had low proliferation fraction, and a tetraploid DNA pattern (22 cases), and 2) other combinations of HER-2/neu expression and EGFR expression, with a high proliferation fraction and an aneuploid DNA pattern (38 cases). Eight cases of carcinoma in situ were positive for HER-2/neu overexpression and negative for EGFR expression, and had a high proliferation fraction and a tetraploid DNA pattern. Twenty-six cases of low-grade carcinoma exhibited low proliferation and a diploid DNA pattern.

Pre-analytical variation in alanine aminotransferase.

To determine the effect of pre-analytical variation of alanine aminotransferase in blood specimens with normal activity concentrations of this enzyme, we stored serum and whole blood samples at 4 and 22 degrees C and assayed aliquots of each specimen at intervals up to 72 h. Analysis of variance revealed no statistically significant increase or decrease in activity of the enzyme for up to 72 h in either specimen type, whether stored at room temperature or refrigerated.