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Cytopathology laboratory improvement programs of the College of American Pathologists: Laboratory Accreditation Program (CAP LAP) and Performance Improvement Program in Cervicovaginal Cytology (CAP PAP).

Major programs of the College of American Pathologists (CAP) are directed toward improvement of laboratory practices through peer review, interlaboratory comparison, education, and development of practice standards and guidelines. Two programs provided to cytopathology laboratories, the Laboratory Accreditation Program and the Interlaboratory Comparison Program in Cervicovaginal Cytology, are dedicated to these laboratory improvement principles. In 1996, each of these programs served over 2100 laboratories that provide cytopathology services. This paper reviews the peer development, structure, and administration of the Laboratory Accreditation Program and the Interlaboratory Comparison Program in Cervicovaginal Cytology, focusing on recent and ongoing initiatives to enhance their contribution to continued improvement of gynecologic cytopathology laboratory practices.

Accreditation↗

Interinstitutional comparison of frozen section consultations. A college of American Pathologists Q-Probes study of 90,538 cases in 461 institutions.

OBJECTIVE: To assess concordant, discordant, and deferred diagnosis rates from frozen sections; to determine reasons for discordance; to identify pathologic processes associated with discordant diagnoses; to determine false-positive or false-negative rates for neoplasms; and to identify anatomic sites associated with discordant frozen section diagnoses. DESIGN: Q-Probes study of the College of American Pathologists. PARTICIPANTS: Four hundred sixty-one institutions participating in the Q-Probes program from November 1, 1990, through March 31, 1991. MAIN OUTCOME MEASURES: Concordant and discordant diagnosis rates. RESULTS: The frozen section concordance rate for diagnoses from the aggregate group was 98.58% and the discordance rate was 1.42%, when uncorrected for deferred diagnoses. During the study period, participating institutions accessioned 1,693,331 surgical pathology cases; 90,538 of these cases were evaluated by frozen section consultation, resulting in the examination of 121,668 specimens and 148,506 frozen section blocks. The majority of the frozen section discordances occurred because of misinterpretation of the original frozen section (31.8%), presence of diagnostic tissue in permanent sections of the frozen block when the frozen section was negative (30.0%), and presence of diagnostic tissue in the portion of the specimen not sampled by the frozen section (31.4%). Of the discordant diagnoses, 67.8% had false-negative diagnoses for neoplasm. The pathology processes and anatomic sites represented in discordant diagnoses are also evaluated. CONCLUSIONS: High diagnostic accuracy of frozen section consultations was demonstrated. Frozen sections are used to evaluate a variety of pathologic processes and anatomic sites.

False Negative Reactions↗

[What to do with surgically removed tissues: send it to the pathologist or put it in the medical waste container?].

Clinicians are sometimes in doubt whether or not to send routinely removed tissue to the pathologist, as not every pathological investigation produces relevant findings. It is not easy, however, to select specimens to be investigated. The cost effectiveness of pathological examination should be investigated prospectively in relation to other clinical diagnostic procedures, e.g. if it is decided that it is not cost effective to take biopsies during endoscopy, it may be questioned whether the endoscopy itself is cost effective.

Cost-Benefit Analysis↗

Timeliness of urinalysis: a College of American Pathologists Q-probes study of 346 small hospitals.

OBJECTIVE: To explore preanalytic handling of urinalysis specimens. DESIGN: The study was a College of American Pathologists Q-Probes study consisting of two parts. The first part was a questionnaire about participants' urinalysis practices. The second part required collection of information from four specific urinalysis specimens per shift on 30 consecutive days or from 200 urine specimens, whichever occurred first. SETTING: Three hundred forty-six small hospitals enrolled in the Small Hospital Q-Probes program. MAIN OUTCOME MEASURES: Compliance with guidelines requiring nonrefrigeration and specimen measurement within 2 hours of collection, and identification of practices associated with better performance. RESULTS: Almost 50,000 urinalysis specimens were analyzed. About 68% of the specimens were measured without prior refrigeration, 2.3% were refrigerated before, 17.9% were refrigerated after, and 4.5% were refrigerated before and after arrival in the laboratory. Aggregate analysis indicated that 11.2% of never-refrigerated specimens exceeded the recommended 2-hour time standard before analysis. For inpatients and outpatients, respectively, 64% and 77% of laboratories were able to meet the 2-hour goal 90% of the time. Improved performance was associated statistically with ordering urinalysis stat, an enforced policy of specimen rejection for delayed transport of inpatient specimens, and the listing of a collection time for outpatient specimens. CONCLUSIONS: A large number of urinalysis specimens exceeded current quality guidelines for handling. Laboratories must monitor and improve preanalytic handling of urinalysis specimens.

Hospital Bed Capacity, 100 to 299↗

Protocol for the examination of specimens from patients with carcinoma of the ampulla of Vater: a basis for checklists. Cancer Committee, College of American Pathologists.

A protocol for the pathologic examination and reporting of specimens from patients with carcinoma of the ampulla of Vater has been developed by the Cancer Committee of the College of American Pathologists. The protocol incorporates all basic pathology data of diagnostic and prognostic significance appropriate for the treatment of patients with ampullary carcinoma. The purposes of the protocol are to serve as a basis for the development of checklists, as an outline for full narrative reporting, as a basis for research protocols, or as a guide for other types of synoptic or reporting formats. The protocol is stratified to accommodate the surgical procedures usually employed for carcinomas of the ampulla of Vater, including acquisition of cytologic specimens, incisional biopsy, excisional biopsy, and Whipple procedure (pancreaticoduodenectomy, partial or complete, with or without partial gastrectomy). Explanatory notes detailing specific procedures and rationales for documentation of specific pathologic data are included in the protocol. The protocol uses the staging system for carcinoma of the ampulla of Vater defined by the American Joint Committee on Cancer and the International Union Against Cancer.

Ampulla of Vater↗

The College of American Pathologists, 1946-1996. Quality Assurance Service.

Since its creation in 1970, the College of American Pathologists Quality Assurance Service Committee has provided important and highly respected interlaboratory programs for daily quality control. In 1988, this committee extended its domain by announcing Q-Probes, a unique benchmarking program for laboratory quality assurance. Because of the success and rapid growth of this program during the next 2 years, the Quality Assurance Service Committee expanded into two committees, namely, QAS-QC and QAS-QA, with expertise concentrated, respectively, in quality control and quality assurance. These committees have compiled a history of significant scientific and educational contributions to members, the international laboratory community, other physicians, and patients. New directions for both committees are now underway so that their contributions can continue in the rapidly changing field of pathology and laboratory medicine.

History, 20th Century↗

Some statistical implications of rounding in the College of American Pathologists Survey.

Quantitative measurements of constituent concentrations of Survey specimens are generally recorded to the nearest integer or to the nearest tenth. Questions have arisen as to whether this degree of rounding of measurements is appropriate when available laboratory equipment can determine results more precisely. Statisticians have studied the effects of rounding off on an variety of standard statistical procedures. In this report biases that may result for estimates of the mean and variance from several typical data sets obtained in the 1975 College of American Pathologists (CAP) Survey are examined. The study indicates that the amount of bias in the sample mean and variance is generally minimal.

Analysis of Variance↗

The comprehensive blood bank survey program of the College of American Pathologists, 1974.

Results of the 1974 College of American Pathologists Comprehensive Blood Bank Survey Program show that ABO and Rh typing are still holding their percentage of excellent (99.48%) accuracy. At least some of the errors still occurring are due to clerical mistakes in filling out the forms and not to technical inaccuracy. Antibody detection shows good accuracy but varies, depending on the complexity of the problems--the easier the problem the higher the rate of concurrence, while the more complex the problem the more variance in results. Crossmatching accuracy is 99% correct or better on any but the most complex problems. Some of the problems involving interpretation of autoimmune hemolytic anemia are discussed.

Blood Banks↗

Projecting corporate health plan utilization and charges from annual ICD-9-CM diagnostic rates: a value-added opportunity for pathologists.

OBJECTIVE: To develop an allocation method for corporate health plan resources and expenditures based on annual International Classification of Disease, 9th revision, Clinical Modification (ICD-9-CM) diagnostic rate stratification as a surrogate for disease incidence. DESIGN: A data-mining process was applied to a self-insured corporate health plan database. Annual membership rates of Current Procedural Terminology (CPT) procedure utilization and charges between 1990 and 1994 for a cohort of 7216 continuously employed plan members were stratified according to the annual rates of the 19 major ICD-9-CM diagnostic classifications. The stratified annual CPT utilization and charge rates were analyzed by correlation analysis and one-tailed t test. RESULTS: Laboratory and pathology procedure utilization and charge rates were highly correlated with specific rankings of ICD-9-CM diagnostic classifications. The health plan diagnostic rate, laboratory utilization rate, and all charge rates increased significantly during the 5 study years. CONCLUSION: Although all procedure utilization and charge rates in this health plan increased each year, their proportionality consistently was maintained among diagnostically related groups of patients. By restraining global expenditures, managed health plans conflict with historical utilization and charge patterns. Treating ICD-9-CM diagnostic groups as disease management services within a managed care plan allows procedures and expenses to be allocated according to medical necessity in the context of total membership benefits. For pathologists, who recently were mandated by the Health Care Financing Administration and the Office of Inspector General of the Department of Health and Human Services to become stewards of ICD-9-CM coding, this is a unique opportunity to lead an initiative to perfect managed care. The process will require permanent patient numbers, computerized longitudinal patient records, and standardized coded medical terminology.

Adult↗

The effects of modifying proficiency testing materials on thyroid function test results. A College of American Pathologists Ligand Assay Survey Study.

OBJECTIVE: To gain insight on the matrix effects, and possible clinical implications, resulting from diluting and concentrating proficiency testing survey material used for the measurement of thyroid function tests. DESIGN: To the standard set of five proficiency survey samples, three supplementary "Wildcard" samples were added. These additional samples were manufactured by overfilling and underfilling vials prior to lyophilization so as to vary the thyroxine-binding protein concentrations. Survey participants measured thyroxine, free thyroxine, and the triiodothyronine uptake and related tests on the Wildcard samples. In addition, free thyroxine indices were calculated. SETTING: The first mailing of the 1995 College of American Pathologists (CAP) Ligand Assay--Series 1 Survey. MAIN OUTCOME MEASURES: Results obtained from the regular set of survey samples and the Wildcard set were compared to values expected by the laws of conservation of matter and mass action. PARTICIPANTS: The approximately 2000 participants of the first mailing of the 1995 CAP Ligand Assay--Series 1 Survey. RESULTS: Numerous assays systems did not give the predicted results, including all of the single-step radioimmunoassays for free thyroxine and over three quarters of free thyroxine index determinations. CONCLUSIONS: Varying the dilution of proficiency survey material produced results that were not predicted by the laws of conservation of matter and of mass action. Although these observations may have been the result of matrix effects, one cannot rule out the possibility that certain thyroid assays may not work in clinical situations having abnormal thyroxine-binding protein concentrations.

Data Collection↗

Protocol for the examination of specimens removed from patients with gastric carcinoma: a basis for checklists. Members of the Cancer Committee, College of American Pathologists, and the Task Force for Protocols on the Examination of Specimens From Patients With Gastric Cancer.

A protocol for the pathologic examination and reporting of specimens from patients with gastric carcinoma has been developed by the Cancer Committee of the College of American Pathologists and a multidisciplinary task force of specialists dealing with patients with gastric carcinoma. The protocol incorporates all basic pathology data of diagnostic and prognostic significance appropriate for the treatment of patients with gastric carcinoma. The purpose of the protocol is to serve as a basis for the development of checklists, as on outline for full narrative reporting, as a basis for research protocols, or as a guide for other types of synoptic or reporting formats. The protocol is stratified to accommodate the surgical procedures usually employed for gastric carcinomas, including acquisition of cytologic specimens, incisional endoscopic biopsy, excisional biopsy, and gastric resection (partial or complete). Explanatory notes detailing specific procedures and rationales for documentation of specific pathologic data are included in the protocol. The protocol uses the staging system for gastric carcinoma defined by the American Joint Committee on Cancer and the International Union Against Cancer.

Biopsy↗

Practice parameter for the use of red blood cell transfusions: developed by the Red Blood Cell Administration Practice Guideline Development Task Force of the College of American Pathologists.

A practice parameter has been developed to assist physicians in the therapeutic use of red blood cell transfusions. The developers of this parameter used the best available information from the medical literature, as well as clinical experience and the extensive reality testing required by the College of American Pathologists for approval. In acute anemia, a fall in hemoglobin values below 6 g/dL or a rapid blood volume loss of more than 30% to 40% requires red blood cell transfusions in most patients. However, tissue oxygenation provides a better indication of physiologic need in situations where invasive monitoring provides this information. When these data are not available, heart rate and blood pressure measurements and the nature of bleeding (active, controlled, uncontrolled) supplement the hemoglobin value in guiding the transfusion decision. In sickle cell disease and thalassemias, red blood cells are transfused to prevent acute or chronic complications. Red blood cell transfusions are used in chronic anemias unresponsive to pharmacologic agents based on the patient's symptoms. Guidelines must be altered for neonates who require an increase in hematocrit to above 0.30 to 0.35 when respiratory distress is present. Indications for red blood cell transfusion for the pregnant or postpartum patient are similar to those for the nonpregnant patient. Risks of transfusion, particularly transmissible disease and incompatibility, remain but have been reduced. Thus, red blood cell transfusion continues to be a powerful therapeutic tool when used judiciously and carries less risk than in the recent past.

Adult↗

Premalignant and malignant disease of the breast: the roles of the pathologist.

This review targets the current role of the pathologist in the diagnosis and management of breast disease, a responsibility that evolved along with an increasingly complex approach to human breast cancer. We will focus on the three major areas of this responsibility: premalignancy, highlighting the atypical hyperplasias; the carcinomas in situ, highlighting low grade ductal carcinoma in situ; and the stratification and prognosis of invasive carcinomas. It will be evident that with the advent of an increasingly rich menu of treatment options, the challenge to identify an optimal categorization of breast cancer and its putative precursors is not static.

Breast↗

[Current lymphoma classification: a step forward for pathologists and clinicians].

Non-Hodgkin lymphomas encompass a heterogeneous group of lymphoid malignancies from the clinical as well as from the pathological point of view. Consequently, one condition of optimal communication among pathologists, clinicians and scientific researchers is an adequate classification system. A new classification of lymphomas was proposed in September 1994, the Revised European-American Lymphoma Classification (REAL classification). The REAL classification is aiming at integration of pathological and clinical data, making it possible to distinguish clinical-pathological entities each of which has its characteristic pathological spectrum, clinical evolution and clinical presentation. The REAL classification is based not only on morphological and immunohistochemical but also on molecular and cytogenetic data. Such a system may make it possible to develop specific therapies for specific pathological entities. The REAL classification constitutes an important step forward in haemato-oncology.

Hodgkin Disease↗

Audit of clinical information and diagnoses supplied to the pathologist following biopsy of oral squamous cell carcinomas.

Strict criteria for the biopsy of oral lesions suspected to be squamous cell carcinoma (SCCA) are difficult to find. Evaluation of the patient's history and clinical findings should help the clinician to accurately diagnose oral cancer. Our study attempts to compare and correlate cases that have the histopathologic diagnosis of oral SCCA with the data submitted by the clinician to the oral pathologist. We find the more information the clinician lists in the biopsy request form, the more likely the correct clinical diagnosis of oral SCCA is. We also show that when risk factors such as tobacco and alcohol use are mentioned by the clinician, the percentage of correct clinical diagnosis is increased.

Biopsy↗

Quality control practices for calcium, cholesterol, digoxin, and hemoglobin: a College of American Pathologists Q-probes study in 505 hospital laboratories.

OBJECTIVE: To assess quality control (QC) practices and their impact on hospital laboratories using the College of American Pathologists (CAP) Q-Probes process. DESIGN: Self-directed data gathering, using a questionnaire to determine QC practices, data input forms for 6 months retrospective quality control use and run failure rates, and input forms for 3 months prospective data concerning QC failure rates and corrective steps taken. Participants submitted data for four analytes: calcium, cholesterol, digoxin, and hemoglobin. PARTICIPANTS: Laboratories enrolled in the 1994 CAP Q-Probes program. MAIN OUTCOME MEASURES: Retrospective and prospective QC failure rates compared with QC protocols and the corrective steps. RESULTS: Five hundred five hospital laboratories returned various components of the study. Median retrospective run rejection rates per 1000 runs: calcium, 4.3; cholesterol, 3.6; digoxin, 4.3; and hemoglobin, 2.4. Corresponding median prospective run rejection rates per 1000 runs: calcium, 5.8; cholesterol, 5.6; digoxin, 6.5; and hemoglobin, 3.6. Participants resolved most out-of-control events in less than 20 minutes, with no patient samples repeated. More than 95% of the time, participants resolved out-of-control events simply by repeating controls. Most participants used a single control rule based on a target mean plus or minus a multiple of the standard deviation. A few laboratories used multirule systems. CONCLUSIONS: Current testing methods yield few out-of-control events, which usually are resolved rapidly, with little impact on laboratory operation. We recommend modification and simplification of laboratory QC practices to decrease false rejection rates and to use modern instrumentation more efficiently.

Calcium↗

Speech-language pathologists' knowledge of, exposure to, and attitudes toward oral myofunctional phenomena.

A questionnaire developed by the authors was completed by 75 experienced speech-language pathologists from varied work settings. Questions dealt with knowledge, attitudes and experience in the area of oral myofunctional disorders. Only 18 respondents listed their classroom instruction in this area as adequate; only six related their practicum experience as adequate. In spite of the limited training reported by the clinicians, 32% were actively providing treatment for clients with oral myofunctional disorders. There was general agreement concerning the importance of training in this area.

Attitude of Health Personnel↗

Interinstitutional comparison of bedside blood glucose monitoring program characteristics, accuracy performance, and quality control documentation: a College of American Pathologists Q-Probes study of bedside blood glucose monitoring performed in 226 small hospitals.

OBJECTIVES: To assess the accuracy of bedside blood glucose monitoring (BGM) in small hospitals, to assess the compliance with which hospital workers performing bedside BGM adhere to quality control (QC) procedures, and to identify those practice characteristics in small hospitals that are associated with better BGM accuracy and with better performance of BGM QC. DESIGN: Over a 1-month period in 1996, voluntary participants in the College of American Pathologists Q-Probes laboratory quality improvement program prospectively compared glucose results of 30 split samples run on BGM instruments with those performed on laboratory glucose analyzers, collected quality control data on up to five inpatient BGM instruments, and completed questionnaires profiling BGM practice characteristics in their institutions. SETTING AND PARTICIPANTS: Two hundred twenty-six hospitals with 200 or fewer occupied beds. MAIN OUTCOME MEASURES: The percentages of glucose determinations performed on BGM instruments differing by more than 10%, 15%, and 20% from those split-sample results performed on laboratory glucose analyzers; the percent of BGM QC determinations required by institutions' BGM QC programs that BGM operators actually performed; and the percent of patient values reported when BGM QC was documented to be out of range and uncorrected, or reported when BGM QC was not performed at all. RESULTS: Of 6095 split-specimen glucose results that participants simultaneously performed on BGM instruments and on laboratory glucose analyzers, 45.6% differed from each other by more than 10%, approximately 25% differed from each other by more than 15%, and almost 14% differed from each other by more than 20%. Of 216 laboratories that performed at least 30 QC events during the study period, slightly over a third completed 100% of their required QC determinations, and 10% completed, at most, 77% of their required BGM QC determinations. Of 115,973 BGM determinations that participants reported on hospitalized patients, 3.3% were reported when QC was either out of range or when there was no documentation that QC had been performed at all. Better accuracy and/or better QC performance was associated with laboratory personnel rather than nursing personnel both supervising institutions' BGM QC programs and running institutions' daily routine BGM QC; with BGM operators both routinely running three, rather than two, levels of QC analytes; with BGM operators regularly comparing BGM results with laboratory analyzer glucose results; and with institutions participating in external proficiency programs. Institutions that completed all required BGM QC tasks tended to perform better on the BGM accuracy study than did those institutions that completed, at most, 77% of their required QC. CONCLUSIONS: We found the rates of BGM accuracy and of QC performance adequacy achieved in small hospitals to be similar to those determined in previous Q-Probes studies conducted in large institutions. A significant amount of institutional bedside testing does not meet current standards for accuracy or for quality control. Some institutions may improve their accuracy and/or QC performances by having laboratory personnel intimately involved in their institution's BGM QC program, by routinely comparing BGM results with those performed using glucose analyzers in the clinical laboratory, by routinely running three rather than two glucose QC control levels, by participating in external proficiency programs, and by strictly adhering to institutional QC protocols.

Australia↗