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At least 883 records · Page 49Linked to original sources
PubMed1998

Amended reports in surgical pathology and implications for diagnostic error detection and avoidance: a College of American Pathologists Q-probes study of 1,667,547 accessioned cases in 359 laboratories.

OBJECTIVES: To evaluate amended report rates relative to surveillance methods and to identify surveillance methods or other practice parameters that lower amended report rates. DESIGN: Participants in the 1996 Q-Probes quality improvement program of the College of American Pathologists were asked to prospectively document amended surgical pathology reports for a period of 5 months or until 50 amended reports were recorded. The methods of error detection were also recorded and laboratory and institutional policies surveyed. Four types of amended reports were investigated: those issued to correct patient identification errors, to revise originally issued final diagnoses, to revise preliminary written diagnoses, and to revise other reported diagnostic information that was significant with respect to patient management or prognosis. PARTICIPANTS: Three hundred fifty-nine laboratories, 96% from the United States. RESULTS: A total of 3147 amended reports in all four categories from a survey of 1,667,547 surgical pathology specimens accessioned during the study period were issued by the participants. The aggregate mean rate of amended reports was 1.9 per 1000 cases (median, 1.5 per 1000 cases). Of these, 19.2% were issued to correct patient identification errors, 38.7% to change the originally issued final diagnosis, 15.6% to change a preliminary written diagnosis, and 26.5% to change clinically significant information other than the diagnosis. Most frequently, a request from a clinician to review a case (20.5%) precipitated the error detection. Although not statistically significant, a higher amended report rate (1.6 per 1000) for all error types was associated with routine diagnostic slide review that was performed after completion of the surgical pathology report. This is compared to rates for institutions that had routine diagnostic slide review of cases prior to finalization of pathology reports (1.2 per 1000) and institutions that had no routine diagnostic slide review (1.4 per 100). Slide review of cases prior to completion of reports lowered the rate of amended reports issued for two types of amended reports: those in which the originally issued final diagnosis was changed and those in which information other than the diagnosis was changed for patient management or prognostic significance. Other laboratory practice variables examined were not found to be associated with the amended report rate. CONCLUSIONS: There is an association between lower amended report rates and diagnostic slide review of cases prior to completion of the pathology report. The level of case review and type of case mix that is necessary for optimal quality assurance needs further investigation.

Diagnostic Errors↗
PubMedDate not supplied

Primary pulmonary hypertension: pathologist as patient.

We describe the case of Julia Polak, an internationally known pathologist with an interest in primary pulmonary hypertension, a condition which she was subsequently diagnosed to have. This was successfully treated by heart/lung transplantation and she was then in the unique position to study and present her own pulmonary pathology. Professor Polak's case illustrates the difficulty in diagnosis, the frequent failure of medical treatment and an excellent outcome from heart/lung transplantation. Based on a presentation to a clinico-pathological conference at Hammersmith Hospital.

Adult↗
PubMed1998

The accuracy of laboratory measurements in clinical chemistry: a study of 11 routine chemistry analytes in the College of American Pathologists Chemistry Survey with fresh frozen serum, definitive methods, and reference methods.

CONTEXT: Better procedures are needed whereby national proficiency testing survey providers can assess and improve the accuracy of laboratory measurements in clinical chemistry. SETTING: The 1994 College of American Pathologists Comprehensive Chemistry Survey. DESIGN: This study of matrix effects and the accuracy of laboratory measurements for 11 analytes linked the logistics of the Survey to definitive methods at the National Institutes of Standards and Technology, reference methods at the Centers for Disease Control and Prevention, proficiency testing materials, and a fresh frozen serum sample. The data were analyzed with a statistical model of laboratory measurements. RESULTS: (1) Matrix biases affected the results reported from 69% of the 644 peer group/survey specimen pairs evaluated. (2) Because of matrix biases, the reference value was the correct target value only 32% of the time; thus, the traceability established by definitive method and reference method value assignments on Chemistry Survey specimens did not assure accuracy on patient samples. (3) In contrast to matrix biases, the error caused by random matrix effects with proficiency testing samples was about the same as that caused by random specimen effects with fresh frozen serum, and both were less than within-run random analytic error. (4) Calibration biases occurred in 73% of the 180 peer groups evaluated, and, after matrix biases were removed, the total variance of interlaboratory measurements was due to peer group calibration bias (48%), within-peer-group random calibration error (31 %), within-run random error (14%), and random specimen effects (7%). CONCLUSIONS: An opportunity exists to improve method calibration accuracy in clinical chemistry. With improved design, national proficiency testing surveys can monitor and help reduce method calibration error by converting reported survey results to a true accuracy base that predicts accuracy on patient samples. For medical purposes, the correct target values on artificial (matrix-modified) chemistry materials are reference values adjusted for the matrix bias of each peer group. Matrix biases estimated by the use of fresh frozen serum can be used as factors to transfer the accuracy of definitive methods from artificial reference materials to patient samples.

Bias↗
PubMed1998

REAL classification of malignant lymphomas in the Republic of Korea: incidence of recently recognized entities and changes in clinicopathologic features. Hematolymphoreticular Study Group of the Korean Society of Pathologists. Revised European-American lymphoma.

BACKGROUND: The clinicopathologic characteristics of malignant lymphomas vary according to geography. The aim of this study was to determine the clinical characteristics of malignant lymphomas and the relative frequency in the Republic of Korea of lymphomas belonging to the newly described REAL (revised European-American lymphoma) classification categories. METHODS: The Hematolymphoreticular Study Group of the Korean Society of Pathologists conducted a consensus-based morphologic review of a nationwide collection of 1548 malignant lymphomas, including Hodgkin's disease (HD), diagnosed at 23 institutes over a recent 2-year period. Slides stained with hematoxylin and eosin or other immunohistochemical stains were reviewed. All cases were classified according to the histologic criteria proposed by the International Lymphoma Study Group. Clinical data, including age, gender, and site of disease involvement, were reviewed. RESULTS: The Republic of Korea had lower rates of HD and follicle center lymphoma and higher rates of extranodal lymphoma, diffuse large B-cell lymphoma, and angiocentric lymphoma compared with Western countries. The most frequent subtypes of non-Hodgkin's lymphoma (NHL) were diffuse large B-cell lymphoma, extranodal marginal zone B-cell lymphoma, peripheral T-cell lymphoma, unspecified type, and angiocentric lymphoma, in decreasing order. Compared with a previous nationwide study, the rates for follicular lymphoma and NHL involving the stomach, orbit, and central nervous system were increased. The rate of T-cell NHL in the current study was much lower than that reported in a previous study for the Republic of Korea and was also lower than that reported for other Far East countries. For HD, the relative frequency of nodular sclerosis subtype was higher compared with that in the previous study, and lymphocyte predominance and lymphocyte depletion were lower. CONCLUSIONS: The occurrence rates for various subtypes of malignant lymphoma in the Republic of Korea are distinct from those in Western countries and similar in many ways to those in other countries in the Far East. Compared with other Far East countries, the Republic of Korea has a higher rate of extranodal lymphoma, rare adult T-cell lymphoma, and a relatively low rate of T-cell lymphomas. It appears that over time there have been changes in the relative rates for follicular lymphoma, subtypes of Hodgkin's disease, and gastric and orbital lymphoma. The authors attribute these changes primarily to refined criteria for diagnosing new clinicopathologic entities.

Adolescent↗
PubMed1998

College of American Pathologists Conference XXXI on laboratory monitoring of anticoagulant therapy: laboratory monitoring of oral anticoagulant therapy.

OBJECTIVE: To review the state of the art of laboratory monitoring of oral anticoagulant therapy, as reflected by the medical literature and the consensus opinion of recognized experts in the field, and to make recommendations for improvement in laboratory monitoring of oral anticoagulant therapy. DATA SOURCES: Review of the medical literature, primarily from the last 10 years, and current laboratory practices by a panel of 8 international experts in the field of oral anticoagulant monitoring. DATA EXTRACTION AND SYNTHESIS: After an initial assessment of the literature, key points were identified. Experts were assigned to do an in-depth review of the literature and current practices relevant to each of the key points and to prepare a summary of their findings and recommendations. A draft manuscript was prepared and circulated to every participant in the College of American Pathologists Conference XXXI on Laboratory Monitoring of Anticoagulant Therapy prior to the conference. Each of the key points and associated recommendations was then presented for discussion at the Conference. Recommendations were accepted if a consensus of the 26 experts attending the Conference was reached. The results of the discussion were used to revise the manuscript into its final form. CONCLUSIONS: Consensus was reached on 12 recommendations concerning the laboratory monitoring of oral anticoagulant therapy. Detailed discussion of the rationale for each of these recommendations is found in the text of this article. Discussion of points on which consensus was not reached is also included in the text. It is hoped that widespread adoption of these recommendations will further improve the laboratory monitoring of oral anticoagulant therapy.

Administration, Oral↗
PubMed1998

College of American Pathologists Conference XXXI on laboratory monitoring of anticoagulant therapy: the clinical use and laboratory monitoring of low-molecular-weight heparin, danaparoid, hirudin and related compounds, and argatroban.

OBJECTIVE: To review the role of the laboratory in monitoring therapy with low-molecular-weight heparin, danaparoid, hirudin, and argatroban, as reflected in the medical literature and the consensus opinion of recognized experts in the field. DATA SOURCES: Review of the medical literature and current clinical practice by a panel of 6 international experts in the field of anticoagulant therapy. DATA EXTRACTION AND SYNTHESIS: The experts made an extensive review of the published literature and prepared a draft manuscript, which included preliminary recommendations. The draft manuscript was circulated to participants in the College of American Pathologists Conference XXXI on Laboratory Monitoring of Anticoagulant Therapy prior to the conference. The manuscript and recommendations were then presented at the Conference for discussion. Recommendations were accepted if a consensus of the 26 experts attending the Conference was reached. The results of the discussion were used to revise the manuscript into its final form. CONCLUSIONS: This report reviews the mechanism of action and potential uses of these newer anticoagulant agents. General guidelines for monitoring these agents and 9 specific recommendations for laboratory monitoring of low-molecular-weight heparin and danaparoid are provided, along with citation of the appropriate supporting literature. Issues for which a consensus was not reached at the Conference are also discussed.

Anticoagulants↗
PubMed1998

Early morning blood collections: A College of American Pathologists Q-Probes study of 657 institutions.

OBJECTIVE: To determine specimen collection and report times, and delivery, analytic, and total turnaround times (TAT) for routine early morning blood collections. DESIGN: The study was a 2-part College of American Pathologists Q-Probes study. In the first part, participants recorded specimen collection times, receipt in testing laboratory times, and test report times for all routine hemoglobin and potassium samples collected between the hours of 1 AM and 10:30 AM on one intensive care unit and one nonintensive care unit for a 1-week period. In the second part, participants provided information about their specimen collection, delivery, processing, analytic, and reporting practices in a questionnaire. SETTING: An intensive care unit and a nonintensive care unit in 657 institutions. MAIN OUTCOME MEASURES: Median collection time, delivery time, analytic time, total turnaround time, and report time. RESULTS: Median institutional collection times ranged from 3 AM to 9:20 AM, with the institution at the 50th percentile reporting a median collection time of 6 AM. Median institutional report times ranged from 3:45 AM to 12: 20 PM, with the institution at the 50th percentile reporting a median report time of 7:23 AM. Median delivery, analytic, and total turnaround times for the median institution were 25, 42, and 73 minutes, respectively. CONCLUSIONS: Factors shown to correlate with shorter total turnaround times were rural locations, a lower collections to full-time equivalent ratio, intensive care unit specimens, plasma for potassium measurements, the practice of delivering each specimen as it is collected, pneumatic tube delivery system, direct delivery route, and continuous versus batch testing.

Blood Specimen Collection↗
PubMed1998

Blood culture contamination: a College of American Pathologists Q-Probes study involving 640 institutions and 497134 specimens from adult patients.

OBJECTIVE: To examine clinical and laboratory practices associated with contamination of blood culture specimens from adults. DESIGN AND SETTING: A College of American Pathologists Q-Probes quality improvement study involving prospective evaluation of adult blood culture contamination rates in 640 institutions. MAIN OUTCOME MEASURE: Proportion of contaminated blood cultures. RESULTS: A total of 497134 blood cultures were studied. The median adult inpatient blood culture contamination rate was 2.5% (central 80th percentile=0.9%-5.4%) by laboratory assessment. There was no significant difference in contamination rates between inpatient and outpatient cultures (P=.273). The median contamination rate by clinical assessment (2.1%) was significantly lower (P=.005), primarily because of a lower proportion of cultures with coagulase-negative Staphylococcus that were interpreted as contaminants when only one of multiple specimens was positive. Specimen collection variables associated with significantly lower contamination rates included use of a dedicated phlebotomy service (P=.039), use of tincture of iodine for skin disinfection (P=.036), and application of an antiseptic to the top of the collection device before inoculation (P=.018). Teaching institutions and high numbers of occupied beds were demographic factors associated with higher contamination rates for inpatients but not for outpatients. Culture parameters associated with higher contamination rates included microbial growth from a single specimen, isolation of certain microbial species (eg, coagulase-negative Staphylococcus), and longer time to detect growth in culture. Contamination rates were not significantly affected by the type of blood culture method used, specimen volume, or use of a double-needle collection procedure. CONCLUSIONS: There is wide variation in blood culture contamination rates among institutions. Three specimen collection factors and three culture variables were identified as having a significant effect on blood culture contamination.

Adult↗
PubMed1998

Benign breast changes and the risk for subsequent breast cancer: an update of the 1985 consensus statement. Cancer Committee of the College of American Pathologists.

The Cancer Committee of the College of American Pathologists has prepared an update of the consensus statement on premalignant breast lesions and breast cancer risk that was originally published in the Archives of Pathology & Laboratory Medicine in 1986. The objective of this publication is to better define the relative breast cancer risk associated with specific histologic abnormalities by incorporating data derived from recent case-control studies. Explanatory notes are used to document and explain specific risk classifications. In addition to refining the degree of risk associated with individual lesions, such as fibroadenoma and atypical hyperplasia, this update includes a discussion of age-specific breast cancer risk and provides examples that can be used when counseling patients.

Age Factors↗
PubMedDate not supplied

Impact of curricular change in an undergraduate program for speech pathologists on perceived preparedness for the workplace.

Recently, educational policymakers have emphasized the need for undergraduate programs to develop in their graduates generic skills and attributes beyond discipline-specific skills and knowledge. The generic skills and attributes should mesh with the requirements of the workplaces where the graduates will find employment. The present study examined the impact of curricular revisions to a program of study for speech pathologists on the perceptions of the graduates regarding their preparation in appropriate skill and knowledge domains. The curricular revisions sought to develop independent learning, critical thinking, research and evaluation skills, written and oral communication skills, and skills for seeking and providing support to peers. Seventy-eight graduates of the earlier program and 21 graduates of the revised program offered by the School of Communication Disorders at The University of Sydney completed a 52-item questionnaire concerning the extent to which the program had equipped them for the workplace. Eleven scales were derived from the questionnaire responses, reflecting skills endorsed by university educators and workplace supervisors of allied health professionals as being necessary for success in the workplace. The relative levels of perceived preparation on the 11 dimensions were similar across graduates of the revised program and those of the earlier program. Graduates of the revised program were significantly more positive about their preparation on five of the 11 dimensions, compared with earlier graduates of approximately equivalent age and experience. The dimensions where differences were observed generally reflected those targeted by the curricular revisions.

Adult↗
PubMed2003

Five-year follow-up of routine outpatient test turnaround time: a College of American Pathologists Q-Probes study.

CONTEXT: Timely reporting of outpatient tests can increase efficiency of care and improve customer satisfaction. OBJECTIVES: We conducted a survey in 2002 to determine how quickly hospital-based laboratories turned around routine requests for 3 common assays and compared the results with a similar survey conducted in 1997. DESIGN: One hundred eighteen laboratories prospectively recorded the collection-to-verification turnaround time for 9252 complete blood cell counts (CBCs), 8832 thyroid tests, and 9193 basic metabolic panels. RESULTS: The median facility reported all test results by 7:00 am of the weekday immediately after the date of specimen collection. The bottom 10% of institutions reported 99% of CBCs and basic metabolic panels within 1 day and 60% of thyroid tests within 1 day. The 65 institutions that participated in both the 1997 and 2002 surveys showed significant overall improvement in turnaround time for all 3 types of tests (P <.001). In 2002, federal institutions had significantly slower turnaround times than nonfederal institutions for CBC tests (P <.001), thyroid tests (P =.03), and basic metabolic panels (P <.001). Other demographic and practice variables were not associated with turnaround time. CONCLUSION: The turnaround time of routine outpatient tests appears to have improved between 1997 and 2002.

Blood Cell Count↗
PubMed2004

Heparin monitoring and patient safety: a College of American Pathologists Q-Probes study of 3431 patients at 140 institutions.

CONTEXT: Appropriate laboratory monitoring of unfractionated heparin therapy promotes effective anticoagulation while minimizing hemorrhagic complications. OBJECTIVES: To measure heparin therapy monitoring in a "real-world" setting and to assess the degree of anticoagulation achieved. DESIGN: One hundred forty institutions abstracted laboratory and pharmacy data from up to 30 inpatients receiving standard-dose unfractionated heparin therapy for 72 hours. Institutions also reported their therapeutic ranges and described heparin prescribing and monitoring policies. RESULTS: Activated partial thromboplastin times or anti-factor Xa levels were measured at least once within the first 12 hours of administration for 95% of 3431 heparinized inpatients. Eighty-seven percent of patients had a platelet count performed within 72 hours of heparin administration. Seventy-eight percent of heparinized inpatients achieved therapeutic anticoagulation within 24 hours, but more than one third of patients entered the supratherapeutic range on at least 2 occasions during the first 72 hours. We found moderate variation in performance among the 140 institutions participating in the study, with more consistency in monitoring patients but less consistency in achieving therapeutic levels of anticoagulation. In one fourth of hospitals, more than half of the heparinized patients entered the supratherapeutic range on 2 or more occasions during the first 72 hours of therapy. None of 20 institutional practices we examined were meaningfully associated with more thorough monitoring of patients or with a higher percentage of patients achieving therapeutic anticoagulation. There was moderately wide variation in therapeutic ranges among the 140 sites. CONCLUSIONS: The prevention of heparin over-anticoagulation represents an important opportunity for improving patient safety in a significant number of institutions.

Anticoagulants↗
PubMed2005

Staffing benchmarks for clinical laboratories: a College of American Pathologists Q-probes study of staffing at 151 institutions.

CONTEXT: Inadequate staffing of clinical laboratories may compromise quality and throughput, whereas excess staff unnecessarily increases the cost of testing. OBJECTIVES: To measure productivity of technical staff and management span of control in a large number of laboratories and to determine factors associated with favorable staffing ratios. DESIGN: A total of 151 clinical laboratories provided information about technical and management staffing and output (workload) for 4 laboratory sections: anatomic pathology, chemistry/hematology/immunology, microbiology, and transfusion medicine. RESULTS: For each laboratory section, there was wide variation in labor productivity (output per nonmanagement full-time equivalent) and in management span of control (nonmanagement full-time equivalent per manager). Productivity ratios for the 10th- and 90th-percentile laboratories varied more than 3-fold. Except in histology, laboratory sections with higher test volumes had higher labor productivity (P < .001 for cytology, chemistry/hematology, and transfusion medicine; P = .003 for microbiology). Even within peer groups composed of sections with similar volume, there was wide variation in labor productivity. A number of variables other than test volume were associated with labor productivity and management span of control. Staffing ratios for each laboratory section and for sections of different sizes are presented. CONCLUSIONS: Despite standardization of testing methods in the clinical laboratory industry, there is wide variation in staffing level among institutions. This variation suggests opportunities to improve staff productivity in many facilities.

Benchmarking↗
PubMed2006

Identification errors involving clinical laboratories: a College of American Pathologists Q-Probes study of patient and specimen identification errors at 120 institutions.

CONTEXT: Misidentified laboratory specimens may cause patient injury, but their frequency in general laboratory practice is unknown. OBJECTIVES: To determine (1) the frequency of identification errors detected before and after result verification, (2) the frequency of adverse patient events due to specimen misidentification, and (3) factors associated with lower error rates and better detection of errors. DESIGN: One hundred twenty clinical laboratories provided information about identification errors during 5 weeks. RESULTS: In aggregate, 85% of errors were detected before results were released; one quarter of laboratories identified more than 95% of errors before result verification. The overall rate of patient identification errors involving released results was 55 errors per 1,000,000 billable tests. A total of 345 adverse events were reported. Most of the adverse events caused material inconvenience to the patients but did not result in any permanent harm. On average, adverse events resulted from 1 of every 18 identification errors. Extrapolating the adverse event rate observed in this study to all United States hospital-based laboratories suggests that more than 160,000 adverse events per year result from misidentification of patients' laboratory specimens. CONCLUSIONS: Identification errors are common in laboratory medicine, but most are detected before results are released, and only a fraction are associated with adverse patient events. Even when taking into consideration the design of this study, which used imperfect case finding, institutions that did a better job of detecting errors within the laboratory released a smaller proportion of results that involved specimen misidentification.

Diagnostic Errors↗
PubMed2006

The CD117 immunohistochemistry tissue microarray survey for quality assurance and interlaboratory comparison: a College of American Pathologists Cell Markers Committee Study.

CONTEXT: We have developed tissue microarray-based surveys to allow laboratories to compare their performance in staining predictive immunohistochemical markers, including proto-oncogene CD117 (c-kit), which is characteristically expressed in gastrointestinal stromal tumors (GISTs). GISTs exhibit activating mutations in the c-kit proto-oncogene, which render them amenable to treatment with imatinib mesylate. Consequently, correct identification of c-Kit expression is important for the diagnosis and treatment of GISTs. OBJECTIVE: To analyze CD117 immunohistochemical staining performance by a large number of clinical laboratories. DESIGN: A mechanical device was used to construct tissue microarrays consisting of 3 x 1-mm cores of 10 tumor samples, which can be used to generate hundreds of tissue sections from the arrayed cases, suitable for large-scale interlaboratory comparison of immunohistochemical staining. RESULTS: An initial survey of 63 laboratories and a second survey of 90 laboratories, performed in 2004 and 2005, exhibited >81% concordance for 7 of 10 cores, including all 4 GIST cases, which were immunoreactive for CD117 with >95% staining concordance. Three of the cores achieved less than 81% concordance of results, possibly due to the presence of foci of necrosis in one core and CD117-positive mast cells in 2 cores of CD117-negative neoplasms. CONCLUSIONS: There was good performance among a large number of laboratories performing CD117 immunohistochemical staining, with consistently higher concordance of results for CD117-positive GIST cases than for nonimmunoreactive cases. Tissue microarrays for CD117 and other predictive markers should be useful for interlaboratory comparisons, quality assurance, and education of participants regarding staining nuances such as the expression of CKIT by nonneoplastic mast cells.

Biomarkers, Tumor↗