PubMed · 3719201
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P L Wright. 1986. The long case.. https://pubmed.ncbi.nlm.nih.gov/3719201/
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CONTEXT: Specific regulation of laboratories performing molecular genetic tests may be needed to ensure standards and quality assurance (QA) and safeguard patient rights to informed consent and confidentiality. However, comprehensive analysis of current practices of such laboratories, important for assessing the need for regulation and its impact on access to testing, has not been conducted. OBJECTIVE: To collect and analyze data regarding availability of clinical molecular genetic testing, including personnel standards and laboratory practices. DESIGN: A mail survey in June 1997 of molecular genetic testing laboratory directors and assignment of a QA score based on responses to genetic testing process items. SETTING: Hospital-based, independent, and research-based molecular genetic testing laboratories in the United States. PARTICIPANTS: Directors of molecular genetic testing laboratories (n = 245; response rate, 74.9%). MAIN OUTCOME MEASURE: Laboratory process QA score, using the American College of Medical Genetics Laboratory Practice Committee standards. RESULTS: The 245 responding laboratories reported availability of testing for 94 disorders. Personnel qualifications varied, although all directors had doctoral degrees. The mean QAscore was 90% (range, 44%-100%) with 36 laboratories (15%) scoring lower than 70%. Higher scores were associated with test menu size of more than 4 tests (P = .01), performance of more than 30 analyses annually (P = .01), director having a PhD vs MD degree (P = .002), director board certification (P = .03), independent (P <.001) and hospital (P = .01) laboratories vs research laboratory, participation in proficiency testing (P<.001), and Clinical Laboratory Improvement Amendment certification (P = .006). Seventy percent of laboratories provided access to genetic counseling, 69% had a confidentiality policy, and 45% required informed consent prior to testing. CONCLUSION: The finding that a number of laboratories had QA scores that may reflect suboptimal laboratory practices suggests that both personnel qualification and laboratory practice standards are most in need of improvement to ensure quality in clinical molecular genetic testing laboratories.
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OBJECTIVE: To assemble an international panel of experts to develop consensus recommendations on selected important issues on the use of ultrasonography (US) in trauma care. SETTING: R Adams Cowley Shock Trauma Center, University of Maryland Medical System, Baltimore, Md. The conference was held on December 4, 1997. PARTICIPANTS: A committee of two co-directors and eight faculty members, in the disciplines of surgery and emergency medicine, representing four nations. Each faculty member had made significant contributions to the current understanding of US in trauma. RESULTS: Six broad topics felt to be controversial or to have wide variation in practice were discussed using the ad hoc process: (1) US nomenclature and technique; (2) US for organ-specific injury; (3) US scoring systems; (4) the meaning of positive and negative US studies; (5) US credentialing issues; and (6) future applications of US. Consensus recommendations were made when unanimous agreement was reached. Majority viewpoints and minority opinions are presented for unresolved issues. CONCLUSION: The consensus conference process fostered an international sharing of ideas. Continued communication is needed to advance the science and technology of US in trauma care.