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At least 667 records · Page 37Linked to original sources

HER-2 fluorescence in situ hybridization: results from the survey program of the College of American Pathologists.

CONTEXT: Fluorescence in situ hybridization (FISH) is a common method used to determine HER-2 status in breast cancer. Limited information is available concerning reproducibility of FISH in determining HER-2 gene amplification. OBJECTIVE: To present proficiency testing results of FISH for HER-2 conducted by the Cytogenetics Resource Committee of the College of American Pathologists/American College of Medical Genetics. DESIGN: During the past 5 years, unstained sections from 9 invasive breast carcinomas were used for HER-2 FISH proficiency testing, allowing for comparison of FISH results among a large number of laboratories. Additional data were collected using an educational (ungraded) challenge and supplemental questions in the surveys. RESULTS: The number of laboratories participating in HER-2 FISH proficiency testing has increased steadily during the past 5 years (from 35 in 2000 to 139 in 2004). Reproducibility of test results among laboratories was excellent for breast tumors with low copy number (no HER-2 amplification) and for breast tumors with high copy number (HER-2 amplification). However, there was considerable variation in interpretation of results for a tumor with low-level HER-2 amplification that was tested on 2 separate occasions. Responses to supplemental questions indicated that there was a need for consensus on the use of a separate equivocal/borderline interpretative category and the need for standardization of cutoff values used to define interpretative categories. CONCLUSIONS: The College of American Pathologists proficiency survey programs provide useful information concerning the reproducibility of clinical testing for HER-2 by FISH and reflect clinical interpretation of HER-2 FISH analyses from laboratories across the country.

Adenocarcinoma↗

Papanicolaou tests with mixed high-grade and low-grade squamous intraepithelial lesion features: distinct performance in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytopathology.

CONTEXT: Previous studies have shown that in gynecologic cytology, cases of low-grade squamous intraepithelial lesion (LSIL) and high-grade squamous intraepithelial lesion (HSIL) perform differently on interpretive review. The performance of cases with mixed LSIL and HSIL features is unknown. OBJECTIVE: To compare the performance of gynecologic cytology cases of "pure" LSIL and HSIL with cases showing mixed LSIL and HSIL features. DESIGN: We compiled performance data from the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytopathology from the years 2003 and 2004, and compared the performance of slides showing relatively pure LSIL and HSIL (< or = 10% misclassification as HSIL and LSIL, respectively) with slides showing mixed LSIL or HSIL features (cases misclassified as LSIL or HSIL > 10% of the time). RESULTS: Interpretations from a total of 4508 cases (2452 HSIL and 2056 LSIL) were analyzed. Overall, the sensitivity of participants on slides with a reference diagnosis of HSIL was 97.3%, and of LSIL was 95.9%. Performance trends for pure versus mixed cases varied by slide type and reference diagnosis. For conventional slides, participant sensitivity on pure HSIL cases was greatest (98.0%) and on pure LSIL cases was least (95.2%), while participant performance on cases with mixed features was intermediate (97.0% for mixed HSIL and 96.7% for mixed LSIL). In contrast, participant performance on ThinPrep slides showed the greatest sensitivity for mixed LSIL slides (97.9%), while performance on mixed HSIL slides showed the lowest sensitivity (95.7%); slides with pure features had intermediate sensitivity levels (96.3% for both HSIL and LSIL). Further evaluation demonstrated that conventional pure HSIL slides performed significantly better than mixed HSIL slides (P = .006), whereas mixed LSIL slides performed better than pure LSIL slides (P = .01). For ThinPrep slides, pure HSIL cases performed similarly to mixed HSIL cases (P = .43), while mixed LSIL cases performed better than pure LSIL cases (P = .04). CONCLUSION: Slides with mixed LSIL and HSIL features have measurably distinct performance characteristics in comparison to slides with pure LSIL or HSIL features. Participant performance on conventional mixed cases is distinctly different from performance on ThinPrep mixed cases.

Diagnosis, Differential↗

Laboratory productivity and the rate of manual peripheral blood smear review: a College of American Pathologists Q-Probes study of 95,141 complete blood count determinations performed in 263 institutions.

CONTEXT: Automated laboratory hematology analyzers are capable of performing differential counts on peripheral blood smears with greater precision and more accurate detection of distributional and morphologic abnormalities than those performed by manual examinations of blood smears. Manual determinations of blood morphology and leukocyte differential counts are time-consuming, expensive, and may not always be necessary. The frequency with which hematology laboratory workers perform manual screens despite the availability of labor-saving features of automated analyzers is unknown. OBJECTIVE: To determine the normative rates with which manual peripheral blood smears were performed in clinical laboratories, to examine laboratory practices associated with higher or lower manual review rates, and to measure the effects of manual smear review on the efficiency of generating complete blood count (CBC) determinations. DESIGN: From each of 3 traditional shifts per day, participants were asked to select serially, 10 automated CBC specimens, and to indicate whether manual scans and/or reviews with complete differential counts were performed on blood smears prepared from those specimens. Sampling continued until a total of 60 peripheral smears were reviewed manually. For each specimen on which a manual review was performed, participants indicated the patient's age, hemoglobin value, white blood cell count, platelet count, and the primary reason why the manual review was performed. Participants also submitted data concerning their institutions' demographic profiles and their laboratories' staffing, work volume, and practices regarding CBC determinations. The rates of manual reviews and estimations of efficiency in performing CBC determinations were obtained from the data. SETTING: A total of 263 hospitals and independent laboratories, predominantly located in the United States, participating in the College of American Pathologists Q-Probes Program. RESULTS: There were 95,141 CBC determinations examined in this study; participants reviewed 15,423 (16.2%) peripheral blood smears manually. In the median institution (50th percentile), manual reviews of peripheral smears were performed on 26.7% of specimens. Manual differential count review rates were inversely associated with the magnitude of platelet counts that were required by laboratory policy to trigger smear reviews and with the efficiency of generating CBC reports. Lower manual differential count review rates were associated with laboratory policies that allowed manual reviews solely on the basis of abnormal automated red cell parameters and that precluded performing repeat manual reviews within designated time intervals. The manual scan rate elevated with increased number of hospital beds. In more than one third (35.7%) of the peripheral smears reviewed manually, participants claimed to have learned additional information beyond what was available on automated hematology analyzer printouts alone. CONCLUSION: By adopting certain laboratory practices, it may be possible to reduce the rates of manual reviews of peripheral blood smears and increase the efficiency of generating CBC results.

Blood Cell Count↗

[Recommendations for anatamo-pathologic management of soft tissue sarcomas in the adult. Pathologists of the FNCLCC Sarcoma Group (Fédération Nationale des Centres de Lutte Contre le Cancer)].

Adult soft tissue sarcomas comprise a heterogeneous group of rare tumors having a wide range of clinical, gross and histological presentations. Outcome is variable. The pathologist's task is difficult but must be based on a rigorous method. The aim of these recommendations is to describe the main steps of management: collection of clinical information, performing biopsy, handling the fresh specimen, gross examination, histological examination, use of special techniques, definition of the main prognostic factors and key features of the pathology report.

Adult↗

CLIA program; approval of the College of American Pathologists--HCFA. Notice.

This notice announces the approval of the College of American Pathologists (CAP) as an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have found that the accreditation process of this organization provides reasonable assurance that the laboratories accredited by it meet the conditions required by Federal law and regulations. Consequently, laboratories that voluntarily become accredited by CAP in lieu of receiving direct Federal oversight and continue to meet CAP requirements would meet the CLIA condition level requirements for laboratories and therefore are not subject to routine inspection by State survey agencies to determine their compliance with Federal requirements. They are, however, subject to validation and complaint investigation surveys.

Accreditation↗

[Cooperation between clinicians and pathologists].

The present review demonstrates, how co-operation between clinicians and pathologists may be improved. In the present work the problems of artefacts introduced in biopsy specimens are discussed. The circumstances that can result in artefacts include: errors by the surgeon or assistant in handling the tissue at the time of biopsy, an improper fixation and faulty tissue processing. Different types of artefacts are described and illustrated and clinical and technical suggestions are given to prevent alterations of normal morphologic and cytologic features that can compromise an accurate diagnosis. In order to avoid diagnostic errors also anamnestic details and rare lesions must be known. The fate of patients suffering from carcinoma is influenced by the stage of the tumour at the time of diagnosis. It may be impossible to diagnose the tumor with the first biopsy even though clinical and macroscopic aspects suggest malignancy. In such a case a new representative biopsy is necessary as rapidly as possible to preserve the organ.

Biopsy↗

Pathologists in New Jersey--an endangered species.

Pathologists in New Jersey are compensated in accordance with the rate established by the state's rate review commissions. The author of this article, while granting that the theory is a worthy one, explains that in practice the reimbursement procedure is causing the decline of the quality of health care in New Jersey.

Facility Regulation and Control↗

The making of a pathologist.

Numerous skills are required of pathologists today, skills so diverse that the traditional formats of residency programs no longer are functional. The author of this article explains what practice in pathology entails, the knowledge of which is essential if residents are to receive the proper training for practice in the field.

Internship and Residency↗

The pathologist as a consultant in a rural area.

In this article, the author discusses some of the problems a pathologist serving as a consultant in a rural hospital may encounter, and ways in which the advisor can maintain good relations with the technologists, physicians, nurses, and administrators.

Consultants↗

The pathologist and the hospital clinical laboratory.

In this article, the author conceptualizes problems in pathology through the perspective of a wide angle lens. He explores how the role of the clinical pathologist evolved into what it is now as well as what, in his view, it ideally should be. The author encourages his peers to analyze, critique, and comment on the opinion he sets forth in the following pages.

Hospital Departments↗

Metamorphosis of a dinosaur or the future role of the clinical pathologist.

Proposing that pathology reorganize, the author introduces a role model for clinical pathology that contains skills and capabilities not currently offered in the clinical practice of medicine. This proposed rebuilding of a clinical discipline, to avoid continued degradation of the pathologist's role in the practice of medicine, will require teaching institutions to instill a new concept of clinical pathology, and the author pinpoints the tool that will be required to make this urgently needed transition to a new type of practice.

Hospital Departments↗

Supply and demand: how many pathologists are needed?

Three different approaches have been used to determine what the supply and demand of pathologists will be in future years. Reviewed in this article are the three manpower studies and the surprising results they yielded.

Health Services Needs and Demand↗

The pathologist and malpractice.

Although malpractice claims in pathology are relatively infrequent, the potential always exists. The author discusses some important areas in which pathologists could be held liable, and illustrates her points by citing some leading cases.

Hospital Departments↗

What do technologists expect of pathologists?

The results of an informal survey that explored technologists' expectations of pathologists are examined in this article. The poll served as the basis of the author's presentation at a CAP seminar titled "Effective Laboratory Communications," held at a past CAP/ASCP Spring Meeting.

Hospital Bed Capacity, 100 to 299↗

The prognosis for the hospital-based pathologist--Part 1.

Both the security and the financial well-being of the hospital-based pathologist have been shaken by ten major developments in the last five years. In this first installment of a two-part article, the authors review these events and the symptoms they have produced. Following their diagnosis, they present a comprehensive plan of treatment.

Hospital Departments↗