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PubMed1993

Accuracy verification and identification of matrix effects. The College of American Pathologists' Protocol.

Proficiency testing using stabilized control materials has been used for decades as a means of monitoring and improving performance in the clinical laboratory. Often, the commonly used proficiency testing materials exhibit "matrix effects" that cause them to behave differently from fresh human specimens in certain clinical analytic systems. Because proficiency testing is the primary method in which regulatory agencies have chosen to evaluate clinical laboratory performance, the College of American Pathologists (CAP) has proposed guidelines for investigating the influence of matrix effects on their Survey results. The purpose of this investigation was to determine the feasibility, usefulness, and potential problems associated with this CAP Matrix Effect Analytical Protocol, in which fresh patient specimens and CAP proficiency specimens are analyzed simultaneously by a field method and a definitive, reference, or other comparative method. The optimal outcome would be that both the fresh human and CAP Survey specimens agree closely with the comparative method result. However, this was not always the case. Using several different analytic configurations, we were able to demonstrate matrix and calibration biases for several of the analytes investigated.

Bias↗
PubMed1993

[PATHOLOGIST --software package for database management systems in pathology].

This article summed up 4 years experiences in the creation and working with software package for collection, processing and storage of data in the form of standard database. Software package--PATHOLOGIST--can be implemented on microcomputer compatible with IBM PC. This package manages 92 relative databases in the order to gather all possible information about performed histological, cytological, immunological examinations as well as autopsy.

Database Management Systems↗
PubMed1995

Experience with distant pathology demonstrations for clinicians in hospitals without local pathologists through the Swedish telepathology work station.

Conferences between pathologists and clinicians are routinely important at each hospital which has its own department of pathology. With the aid of telepathology, such conferences can be facilitated to provide results similar to those in hospitals with their own pathological service. Our Department serves the hospital in Motala, which is located 50 km west of Linköping. We now have telepathology conferences every second week with the surgeons and every second week with colleagues in internal medicine. The equipment we use is LabEye, which is produced by Innovativ Vision AB in Linköping. This equipment includes mouse pointers at both stations which are always visible in the images at both ends of the system. The quality of images received in Motala is very good, allowing discussion of details regarding the specimens, especially the cytological ones. Our experiences with these conferences have been very good.

Hospital Units↗
PubMed1996

Bedside glucose monitoring quality control practices. A College of American Pathologists Q-Probes study of program quality control documentation, program characteristics, and accuracy performance in 544 institutions.

OBJECTIVE: To investigate the adequacy of bedside glucose monitoring (BGM) quality control documentation and monitoring, characterize program structure and organization, and identify characteristics associated with the ability to produce accurate results. DESIGN AND SETTING: College of American Pathologists Q-Probes laboratory quality improvement study in 544 institutions. MAIN OUTCOME MEASURES: Percent compliance with quality control (QC) documentation, appropriate corrective action, and frequency of inappropriate patient testing, and the percentage of BGM results within +/-10% and +/-15% of a corresponding clinical laboratory glucose result. RESULTS: Five hundred forty-four institutions reviewed a total of 19543 individual QC paper documents from 2543 separate BGM instruments. Ninety percent of QC determinations that should have been performed and noted on these documents were recorded; of those performed, 2.8% of QC results were outside of the acceptable range. Thirty-two percent of the out-of-range QC results had no record of corrective action. There were 527 reported instances of one or more patients being tested when there was no record of corrective action for out-of-range QC results. There were 20665 undocumented potential QC events, with 2053 instances of one or more patients being tested when there was no documentation. Two hundred forty-two institutions submitted 6653 paired BGM and clinical laboratory results for comparison. Approximately 56% of BGM results were within +/-10%, and 74% were within +/-15% of the corresponding clinical laboratory result. Factors associated with better accuracy performance are discussed. CONCLUSIONS: There is a need for improving compliance with QC documentation, improving appropriate corrective action follow-through, decreasing the frequency of inappropriate patient testing, and improving BGM accuracy performance. We provide recommendations for improvement.

Blood Chemical Analysis↗
PubMedDate not supplied

[The Lvov school of clinical pathologists].

The story of pathology in Lviv can be briefly summarized in two stages, the first one beginning with 1785 when the University of Lviv medical faculty was organized, the second stage dating back to 1896 when the Medical Institute of Lviv and the department of pathology were found. In 1896 the first autopsy was performed at the pathology department of the Medical Institute of Lviv. Beginning with 1901 the Institute has been conducting postmortal, histological and microbiological investigations; since 1923 they have been obtaining biopsies and operative material, in 1955 histochemistry division was organized, and in 1967 electronic microscopy was first applied to studies and has become accepted practice since then. The beginning of the pathology scientific school in Lviv dates back to the end of the 19th century. It is possible to make out four principal periods of activity at the second stage of the department's development, viz., those between 1896 and 1920, 1920 and 1941, 1945 and 1965, and from 1966 up to the present day. Each of these was approximately of 20 years' duration. During the first period, A. Obzhut and Z. Dmokhovs'kyĭ, eminent pathologists, showed themselves first-rate lenders, the main fields of their activity having been creation of text-books for students, organization of the department's macro-museum, study into inflammation. During the second period it was V. Novits'kyĭ who came to the fore having devoted himself to study of infections diseases, carcinogenesis, problems of goitre; and also known for publication of a three-volume text-book on pathologic anatomy. During the third period the department was headed by M.V. Voĭno-Iasenets'kyĭ and Ie.I. Pal'chevs'kyĭ who distinguished themselves in the study of infectious diseases and endemic pathology. At present, D. Zerbino is in charge of the department of pathology. His principal lines of scientific activity are those of environmental and cardiovascular pathology.

History, 18th Century↗
PubMed1996

Mycobacterial testing in clinical laboratories that participate in the College of American Pathologists Mycobacteriology Surveys. Changes in practices based on responses to 1992, 1993, and 1995 questionnaires.

OBJECTIVE: To determine whether the trend of increasing use of rapid methods of mycobacterial testing among participants in the College of American Pathologists (CAP) Mycobacteriology E Proficiency Testing Survey noted between 1992 and 1993 continued through 1995, and to collect information concerning mycobacterial staining and culture protocols from laboratories that do limited mycobacterial testing. METHODS: The 1993 CAP E Survey questionnaire addressing mycobacterial laboratory practices, test volumes, and rate of recovery of drug-resistant Mycobacterium tuberculosis was included with the CAP 1995 E-A Survey. A shortened list of these same questions, excluding those addressing mycobacterial identification and susceptibility test methods, was added to the CAP 1995 E1-A Survey, to which laboratories that do limited mycobacterial testing subscribe. RESULTS: A total of 802 and 1490 participants in the E and E1 surveys, respectively, returned responses to the CAP by the cutoff date for data analysis. For E Survey participants who answered questions concerning test methods in the years being compared, the percentage who used rapid techniques increased significantly over the study period. More participants used the fluorochrome stain (58% in 1992, 62% in 1993, and 72% in 1995), BACTEC TB plus a solid medium for culture (36% in 1992, 42% in 1993, and 50% in 1995), DNA probes for identification of M tuberculosis (68% in 1993, 79% in 1995), and BACTEC TB for susceptibility testing (65% in 1993, 71% in 1995). The percentages of E1 Survey participants who used a fluorochrome stain for detection of acid-fast bacilli and both a liquid and a solid medium for mycobacterial culture were lower than the percentages of E Survey participants who used these methods. Among participants who responded in all years being compared, the percentage processing respiratory specimens at least 7 times per week increased from 26% in 1992 to 30% in 1993 and 43% in 1995 (P < .001), and the percentages reporting an identification of M tuberculosis within 21 days and susceptibility test results within 28 days increased significantly over the study period (29% in 1992, 40% in 1993, and 56% in 1995 for identification; 13% in 1992, 19% in 1993, and 30% in 1995 for susceptibility testing). Turnaround times for E Survey participants were significantly shorter than those for E1 Survey participants. The number of specimens tested per month appeared to remain relatively stable between 1993 and 1995; however, the number of new patients with tuberculosis and the number of known tuberculosis patients with positive cultures declined significantly. CONCLUSIONS: The recent emphasis placed on utilization of rapid methods of mycobacterial testing appears to have influenced laboratories that subscribe to the CAP E Survey. Significantly more of these laboratories were following the Centers for Disease Control and Prevention's recommendations in 1995 than in 1993 and 1992. However, many laboratories that provide only limited mycobacterial testing still have not adopted the more rapid techniques. Because tuberculosis remains a public health problem, the efforts directed at its control must not wane if the recent downward trend in incidence is to be maintained.

Bacteriological Techniques↗
PubMed1996

Susceptibility testing of Mycobacterium avium complex in clinical laboratories. Results of a questionnaire and proficiency test performance by participants in the College of American Pathologists Mycobacteriology E Survey.

OBJECTIVES: To obtain information regarding the frequency and methodology of susceptibility testing of Mycobacterium avium complex (MAC) in clinical microbiology laboratories, and to assess interlaboratory reproducibility of MAC susceptibility testing. DESIGN: Questions addressing MAC susceptibility testing were added to the College of American Pathologists' 1994 Mycobacteriology E Proficiency Testing Survey, and participants were asked to complete the questionnaire. In addition, participants in the 1994 E Survey were asked to test susceptibility of a MAC isolate recovered from a proficiency testing specimen as an ungraded exercise if they offered such testing for patients. RESULTS: Of the 1003 participants enrolled in the 1994 Mycobacteriology E-A Survey, 806 responded to one or more supplemental questions. In regard to the demand for MAC susceptibility testing, 606 participants indicated that the test is requested by physicians in their institutions, and 188 said that they do the test routinely on at least one MAC isolate per patient. Eighty-two percent (630/765) of participants refer the test to an outside laboratory, most commonly a commercial reference laboratory or state health laboratory. Of the 70 participants who perform MAC susceptibility testing in-house and indicated the method on the questionnaire, 54 (77%) used a solid medium, whereas only 14 (20%) used BACTEC TB, which currently is the recommended method. The most frequently tested drugs were ethambutol, rifampin, isoniazid, and streptomycin; other commonly evaluated agents were ciprofloxacin, amikacin, and clarithromycin. Only eight participants modify the pH of the medium when testing a macrolide. In regard to reporting test results, 56% (45/80) report a qualitative result only, 35% (28/80) report a quantitative result with a qualitative interpretation, and 9% (7/80) report only a quantitative result. Participant performance on the MAC proficiency testing specimen showed lack of interlaboratory reproducibility; 80% or fewer participants reported the correct result for all drugs except amikacin, for which 92% (11/17) of laboratories responded correctly. CONCLUSIONS: Given the obvious interest in MAC susceptibility testing, standardized methodology that demonstrates interlaboratory reproducibility and, optimally, shows some correlation with clinical outcome is needed. Moreover, recommendations concerning indications for performing the test would be useful.

Adult↗
PubMed1996

Atypical squamous cells of undetermined significance. Current laboratory practices of participants in the College of American Pathologists Interlaboratory. Comparison Program in Cervicovaginal Cytology.

OBJECTIVE: To evaluate current laboratory practices and rates for atypical squamous cells of undetermined significance (ASCUS), a category of epithelial cell abnormality in the Bethesda System. DESIGN: Questionnaire surveys were mailed in December 1993 and March 1994. SETTING: Cytopathology laboratory participants in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology (PAP). RESULTS: Most responding laboratories (82.5%) limited the use of "atypia" terminology to abnormalities of undetermined significance. Nearly half of the laboratories employed only the term ASCUS for squamous epithelial changes in this category. The median rate of ASCUS in 1993 was 2.8%, with 10% of laboratories reporting rates greater than 9.0%. The median squamous intraepithelial lesion rate was 2.0%, with a median ASCUS-squamous intraepithelial lesion ratio of 1.3. The majority of laboratories qualified a portion of ASCUS cases and issued recommendations for follow-up when appropriate. Fifty-six percent of laboratories surveyed included patients diagnosed with ASCUS in follow-up programs. Laboratories estimated that about 20% (median response) of patients with ASCUS smears had a squamous intraepithelial lesion or equivalent diagnosis made within a year's follow-up. CONCLUSIONS: The ASCUS category is used by the majority of laboratories as recommended by the Bethesda System, but reporting rates vary. The results of this survey and associated surveys provide laboratories with useful benchmark figures for interlaboratory comparison of ASCUS practices.

Cervix Uteri↗
PubMed1996

Rescreening in gynecologic cytology. Rescreening of 8096 previous cases for current low-grade and indeterminate-grade squamous intraepithelial lesion diagnoses--a College of American Pathologists Q-Probes study of 323 laboratories.

OBJECTIVE: To quantitate, characterize, and analyze errors identified in the rescreening of previous gynecologic cytology specimens with original diagnoses of within normal limits or benign cellular changes for current cases diagnosed as low-grade squamous intraepithelial lesion or squamous intraepithelial lesion of indeterminate grade. DESIGN AND SETTING: College of American Pathologists Q-Probes laboratory quality improvement study in 323 laboratories. MAIN OUTCOME MEASURE: False-negative rate in cases rescreened as a result of a current cytologic diagnosis of low-grade squamous intraepithelial lesion or squamous intraepithelial lesion of indeterminate grade. RESULTS: A total of 8096 smears performed within the 5 years preceding the current examination were rescreened. Of the rescreened cases, 284 (3.5%) were reclassified as a squamous intraepithelial lesion or carcinoma, 474 (5.9%) as atypical squamous cells of uncertain significance, 7 (0.09%) as atypical glandular cells of uncertain significance or glandular intraepithelial lesion, and 39 (0.5%) as unsatisfactory. Ninety-three percent (261/280) of all false-negative cases were identified in cases from the previous 3 years. CONCLUSION: Rescreening archival cytology cases previously diagnosed as within normal limits or benign cellular changes for current cases diagnosed as low-grade squamous intraepithelial lesion or squamous intraepithelial lesion of indeterminate grade will identify screening and diagnostic errors. This may be a useful quality improvement monitor in many laboratories.

Cervix Uteri↗
PubMed1977

Scuba diving deaths: a review and approach for the pathologist.

A series of 34 cases of SCUBA-related fatalities in military personnel from the files of the Armed Forces Institute of Pathology has been presented. It may be concluded that the potential problems that can occur in the hyperbaric aquatic milieu while using scuba are not completely appreciated by pathologists. The resulting investigations of such fatalities give little hard data relevant to such entities as true incidence of barotraumatic injuries, aseptic bone necrosis, and contaminated air supply, the interrelationship of human, environmental, and life support system factors in such fatalities, and the pathophysiologic sequences leading to drowning or death due to causes other than drowning. Hyperbaric pathophysiology is reviewed with the hope that more reasonable interpretations of cause and mechanisms of death will be possible, and the entities air embolism and decompression sickness are differentiated in a similar light. The importance of the type of SCUBA is discussed, through analysis of ten operational diving fatalities, and the possibility of anoxia, hyperoxic convulsions, and hypercapnia existing with the use of rebreather SCUBA is emphasized. A general approach to the medical investigation of a SCUBA fatality is given, under broad headings including on-the-scene investigation, clothing and equipment examination, external and internal examinations, and toxicologic examination.

Adult↗
PubMed1996

The use and abuse of routine stool microbiology: a College of American Pathologists Q-probes study of 601 institutions.

OBJECTIVE: To examine the efficiency with which physicians use routine stool microbiology tests. DESIGN: Questionnaire and structured review of 100 consecutive stool bacteriology and parasitology examinations at each participating institution. SETTING: Six hundred one institutions enrolled in the College of American Pathologists Q-probes Program. RESULTS: Of 59500 bacteriology specimens, 3808 (6.4%) contained a pathogen. The vast majority (99%) of bacterial pathogens were detected in either the first or second specimen submitted. Almost 40% of inpatient specimens were collected after the third day of hospitalization, but only 0.6% of these specimens were positive for enteric pathogens that had not been previously recovered. More than half of the laboratories reported having no limits on the number of bacteriology specimens per patient that could be submitted for testing, and fewer than 8% of laboratories rejected specimens from inpatients after a certain number of days in the hospital. The frequency with which laboratories performed tests for Clostridium difficile varied widely. Of 58500 parasitology specimens, 1463 (2.5%) contained a pathogen; 97.6% of pathogens were detected by the second stool specimen, and 99.8% were detected by the third specimen. Only 0.7% of specimens from inpatients hospitalized more than 4 days contained a new pathogen. CONCLUSIONS: We recommend that no more than two bacteriology specimens and no more that two or three parasitology specimens be processed per patient without consultation. Standard stool examination for a bacterial pathogens has a low yield and should not be performed after 3 days of hospitalization. Likewise, parasitology examinations should not be performed after 4 days of hospitalization.

Clostridioides difficile↗
PubMed1996

The autopsy. Some ethical reflections on the obligations of pathologists, hospitals, families, and society.

Since the 18th century, the autopsy has been seen as an essential tool for advancing medical knowledge and monitoring the quality of patient care. In recent years, based on the mistaken assumption that newer diagnostic antemortem procedures, especially imaging techniques, have rendered the autopsy obsolete, it has fallen into serious disuse and disrepute. Data disproving this assumption are now emerging. The autopsy is still needed as a final test of the newer diagnostic techniques and as a means for integrating anatomic, physiologic, biochemical, and clinical features of new, as well as established, diseases. This essay examines the sources of clinicians' and pathologists' moral obligations to obtain, perform, and attend autopsies. It underscores the ethical responsibilities of families, hospitals, and society to restore the autopsy to a place of importance in the elaboration of the natural history of human disease.

Attitude of Health Personnel↗
PubMed1977

[The significance of the clinical autopsy from the viewpoint of the pathologist].

Selected examples are cited to show that, even today, autopsy can provide the clinician with essential information. The most important task of clinical autopsy is analysis of the individual case and correlation between clinical and autopsy findings. The discrepancies that may arise here are illustrated by cases of endocarditis. Spontaneous or therapeutic alterations of disease forms can only be established by autopsy, as is exemplified by indigenous systemic mycoses. The part autopsy can play in the analysis of new disease entities is illustrated in the case of analgesic nephropathy. From this it emerges that autopsy serves not only to establich terminal states but also the early stages. The example of malignant tumors which eluded clinical diagnosis is cited to demonstrate the value of autopsy statistics. In conclusion, an appeal is made for more intensive cooperation between clinician and pathologist and wider use of modern methods in the evaluation of autopsies.

Aspergillosis↗
PubMed1996

Medicolegal issues. An anatomic pathologist's perspective.

In the practice of anatomic pathology, the standard of care must be met in all instances if the possibility of an adverse legal action is to be avoided. Whether one practices surgical, cyto-, or necropsy pathology, one is at risk. Constant vigilance, following appropriate guidelines, and well-designed quality assurance programs are all important in reducing the possibility of litigation. During intraoperative consultations direct communication with the surgeon is often essential. If an adequate legal defense is to be had, documentation of the precautions taken in an individual case is necessary. Outside consultants should be chosen carefully based on their expertise in the area of concern, and preferably only one consultation should be requested on a particular case. House staff in training should be given graduated responsibility, but their work, in general, should be supervised by an attending pathologist who has hospital privileges. In giving testimony as a defendant, one should never admit a departure or deviation from the standard of care. As an expert witness, it is important that one's testimony be objective and impartial. One should not attempt to answer questions outside one's area of expertise.

Female↗
PubMed1997

The surgical pathologist in a client/server computer network: work support, quality assurance, and the graphical user interface.

Cympathy is a relational client/server database application designed to integrate the departmental work flow in anatomic pathology, segment information appropriately, and allow flexible interaction with standalone microcomputer programs. The database resides in a minicomputer server connected to 40 client microcomputers. Patient histories on consultation requests are scanned and maintained as bitmapped files; all information is stored on fixed disks. Client microcomputers use a graphical interface to update a patient-related status bar and retrieve any of the nearly 40 data entry tables for accessioning, ordering special stains and studies, block and slide production, reports, gross and microscopic findings, evaluation of analyses, Systematized Nomenclature in Medicine (SNOMED) coding, conference scheduling, logging of borrowed materials, queries, and specialized functions such as electron microscopy, including indexes for blocks, grids, and photonegatives. The application radically reduces the need for administrative personnel. Cympathy allows major refinements in the method of composing, distributing, and storing report information. Quality assurance protocols can be expanded to relate the frequency and quantification of microscopic findings retrieved in a structured query to the individual pathologist for a given type of specimen and diagnosis. Such queries can extend output to include the number of blocks and slides and all analyses, services, and procedures applied to each case. Debiting is automated through a flexible dependence on SNOMED codes, analyses, and number of slides generated. Any number of structured queries can be written and saved within Cympathy, addressed directly to the database server, or composed in microcomputer programs linked to the database by open database connectivity drivers. Within Cympathy, query results are output in a fixed table format, which can be expanded to include, for example, tabulations of gross and microscopic findings and analysis results. The application offers the opportunity for research and quality assurance in anatomic pathology without the need for hard copy output.

Databases, Factual↗
PubMed1997

Mammographically directed breast biopsies: a College of American Pathologists Q-Probes study of clinical physician expectations and of specimen handling and reporting characteristics in 434 institutions.

OBJECTIVES: To determine (1) the information that clinical physicians want in surgical pathology reports of biopsies performed for mammographic abnormalities, (2) how specimens are received and processed, and (3) what information is actually present in pathology reports. DESIGN: The standard data collection and questionnaire format of the College of American Pathologists' Q-Probes quality improvement program was used. Laboratories (1) surveyed clinical physicians working in selected specialties involved in the care of patients with breast disease concerning what information they wanted in a surgical pathology report, (2) documented laboratory specimen handling for 20 consecutive breast biopsy tissues obtained to investigate mammographic abnormalities, and (3) documented the information content of surgical pathology reports of these cases. PARTICIPANTS: Four hundred thirty-four participating laboratories surveyed 1469 clinical physicians and collected information on 7300 cases regarding specimen processing and report content. RESULTS: Clinical physicians were unanimous in the majority of items they desired for patient care. The information, however, differed depending on the diagnosis. In processing of tissues, 89% of specimens were received without fixative. In 83% of cases, radiographs were performed. Eighty-two percent of specimens were marked in some manner, but in only 45% of cases was a report of the radiographic abnormality given to the Pathology Department. The median number of blocks used to sample the lesion and the whole specimen was three and six blocks, respectively. The latter correlated with specimen size. Fifty-seven (13%) surgical pathology laboratories had radiography equipment. Radiographs of specimens and tissue blocks were made in 5% and 4% of cases, respectively. Correlation of a mammographic abnormality with a microscopic finding was documented in 62% of reports. In 92% of malignant cases the margin status was reported, and 77% of reports contained the lesion size. Eighty-three percent of reports with invasive carcinoma stated the tumor grade, and 76% stated the extent of intraductal carcinoma. The percentage of reports containing information items was significantly higher (P < .05) for institutions using checklists. SUMMARY: This multi-institutional Q-Probes study describes the current clinical expectations and laboratory practices associated with mammographically directed biopsies. Disparities between pathology reporting and clinician desires, as well as radiology and laboratory specimen handling practices, have been identified and may help focus future quality improvement efforts.

Biopsy↗
PubMed1997

Chemistry specimen acceptability: a College of American Pathologists Q-Probes study of 453 laboratories.

OBJECTIVE: To determine the frequency and reasons for rejection of chemistry specimens. DESIGN AND SETTING: College of American Pathologists Q-Probes laboratory quality improvement study prospectively recording rejected chemistry specimens in 453 laboratories. MAIN OUTCOME MEASURE: Percentage of submitted specimens rejected for testing. RESULTS: Of 10,709,701 chemistry specimens submitted to the participating laboratories during the data collection period, 37,208 (0.35%) were rejected prior to testing. The institutional 10th, 50th (median), and 90th percentiles were 1.35%, 0.31%, and 0.06%, respectively. The most frequent reason for rejection was hemolysis, which occurred five times more frequently than the second most cited reason, insufficient specimen quantity to perform the test. When examined with their respective frequency of use, a higher percentage of rejected specimens were collected in microcollection tubes than in other containers. When compared with the respective frequency with which they collect specimens, laboratory personnel submitted significantly fewer rejected specimens than other in-hospital personnel groups and slightly more than out-of-hospital nonlaboratory personnel. The poorest performance was demonstrated by other in-hospital nonlaboratory personnel. Serum and plasma oxalate/fluoride specimens exhibited significantly lower rejection rates when compared with the other specimen types. Relative rejection rates were higher for nongel tubes and lower for syringes when compared with gel tubes. CONCLUSION: Specimen rejection should be monitored on a regular basis. Institution-specific factors that are associated with rejection should be identified and targeted for improvement efforts. Action thresholds should be set sufficiently low to assure that continuous improvement is effected.

Blood Preservation↗