Frequency of Problems During Clinical Molecular-Genetic Testing

Hofgartner, Wolfgang; Tait, Jonathan F.

doi:10.1093/ajcp/112.1.14

Cited by 49 publications

(29 citation statements)

References 5 publications

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“…On reviewing results from numerous clinical laboratories participating in proficiency testing programs, Westgard and Westgard (18 ) recently demonstrated that estimates on the scale for common clinical chemistry assays are not satisfactory. Unsatisfactory analytical performances have also been described in the fields of immunoassay (19,20 ), coagulation (21 ), hematology (22 ), and molecular biology tests (23 ). It may well be that currently detected analytical errors are only a portion of the total analytical errors.…”

Section: Discussionmentioning

confidence: 99%

Errors in a Stat Laboratory: Types and Frequencies 10 Years Later

Carraro

Plebani²

2007

Clinical Chemistry

536

342

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Background: In view of increasing attention focused on patient safety and the need to reduce laboratory errors, it is important that clinical laboratories collect statistics on error occurrence rates over the whole testing cycle, including pre-, intra-, and postanalytical phases. Methods: The present study was conducted in 2006 according to the design we previously used in 1996 to monitor the error rates for laboratory testing in 4 different departments (internal medicine, nephrology, surgery, and intensive care). For 3 months, physicians and nurses were asked to pay careful attention to all test results. Any suspected laboratory error was recorded with associated pertinent clinical information. Every day, a laboratory physician visited the 4 departments and a critical appraisal was made of any suspect results. Results: Among a total of 51 746 analyses, clinicians notified us of 393 questionable findings, 160 of which were confirmed as laboratory errors. The overall frequency of errors, 3092 ppm, was significantly lower (P <0.05) than in 1996 (4700 ppm). Of the 160 confirmed errors, 61.9% were preanalytical errors, 15% were analytical, and 23.1% were postanalytical. Conclusions: During the last decade the error rates in our stat laboratory have been reduced significantly. As demonstrated by the distribution pattern, the pre-and postanalytical steps still have the highest error prevalences, but changes have occurred in the types and frequencies of errors in these phases of testing.

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Section: Discussionmentioning

confidence: 99%

Errors in a Stat Laboratory: Types and Frequencies 10 Years Later

Carraro

Plebani²

2007

Clinical Chemistry

536

342

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“…The results of survey data from 42 laboratories in this country reported significant errors in 0.33% of tests performed [90]. Of the errors identified, 60% occurred in the pre-analytical phase, 32% in the analytical phase, and 8% in the post-analytical phase.…”

Section: Microbiology and Molecular Biologymentioning

confidence: 96%

Errors in pathology and laboratory medicine: Consequences and prevention

Hollensead

Lockwood

Elin

2004

Journal of Surgical Oncology

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Reducing errors and improving quality are an integral part of Pathology and Laboratory Medicine. The rate of errors is reviewed for the pre-analytical, analytical, and post-analytical phases for a specimen. The quality systems in place in pathology today are identified and compared with benchmarks for quality. The types and frequency of errors and quality systems are reviewed for surgical pathology, cytopathology, clinical chemistry, hematology, microbiology, molecular biology, and transfusion medicine. Seven recommendations are made to reduce errors in future for Pathology and Laboratory Medicine.

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“…In the article by Hofgartner and Tait, 2 three fourths of the laboratories surveyed had directors who were certified by the American Board of Medical Genetics. 2 Ideally, if adequate counseling were not available to patients, laboratories could offer counseling as part of the testing service or refer patients for counseling. However, insufficient numbers of genetic counselors are available in the United States, and the number will almost certainly be inadequate for the large number of molecular genetic tests generated now and in the near future.…”

Section: Robert a Robinson MD Phdmentioning

confidence: 99%

Are We Failing in Molecular Genetic Testing?

Robinson¹

1999

Am J Clin Pathol

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Advances in molecular disease analysis and directed national funding of efforts such as the Human Genome Project have begun to bring potentially valuable information about many diseases through molecular genetic testing. While molecular genetic testing in the clinical laboratory enables identification of patients at risk for a disease process, many clinicians do not fully appreciate the complexity implied in these tests. To begin with, the ease with which preliminary research data have turned into presumed valid genetic testing is of concern. What few understand is that availability of a test that identifies a disease should be only the beginning of a carefully thought out process. However, it is not difficult to set up a genetic testing service. Clinical Laboratories Improvement Act registration and Health Care Financing Administration certification are usually not difficult to obtain. A recent National Institutes of Health (NIH) task force raised concerns about the quality of the laboratories performing genetic tests. Although not required to, most laboratories voluntarily participate in inspections or other programs to assess quality of testing. The NIH group also was concerned that laboratory requirements that do exist for accreditation insufficiently emphasize the preanalytic and postanalytic aspects of the tests.1 While we are justly proceeding with molecular genetic testing, many clinicians and even more patients do not completely understand the data the testing provides. With numerous laboratories performing this technically demanding analysis, enough time has elapsed to begin asking questions about the reliability of molecular genetic testing. In this issue of The Journal, Hofgartner and Tait 2 review the frequency of problems in clinical molecular genetic testing, a relatively new specialty of laboratory testing. As evidenced in their survey, the mean age of a molecular genetics testing laboratory is 6.5 years. This study surveyed laboratories on site (n = 2) and by questionnaire (n = 42 respondents) to determine the incidence of problems in the tests performed and where problems occurred, that is, in the pretest, laboratory, or posttest phase, and attempted to determine the level of actual harm resulting from errors. Approximately 60% of the institutions were academic, 20% private not-for-profit, 12% private forprofit laboratories, and 7% classified as "other." The overall frequency of significant problems was 33% in the questionnaire-surveyed laboratories and 38% in the on-site inspected laboratories. At this reported rate, the frequency of errors in genetic testing is somewhat comparable to that in other areas within the laboratory and in medicine in general. A majority of significant problems occurred in the pretest phase, with inappropriate test selection being the most common in the category. The authors concluded that significant problems during genetic testing occur infrequently, and problems resulting in significant harm to the patient are relatively rare.Genetic tests can carry more inherent...

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Frequency of Problems During Clinical Molecular-Genetic Testing

Abstract: A b s t r a c t Concerns have been raised about the quality of

Cited by 49 publications

References 5 publications

Errors in a Stat Laboratory: Types and Frequencies 10 Years Later

Errors in a Stat Laboratory: Types and Frequencies 10 Years Later

Errors in pathology and laboratory medicine: Consequences and prevention

Are We Failing in Molecular Genetic Testing?

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