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Safe results handling
Published in Paul Bowie, Carl de Wet, Aneez Esmail, Philip Cachia, Safety and Improvement in Primary Care: The Essential Guide, 2020
Paul Bowie, Julie Price, John McKay
The safety and reliability of two-way systems for communicating the ordering of laboratory tests and returned test results at the interface between primary and secondary care is a topic of concern in most healthcare systems.’4,5 However, the focus here is specifically on what happens in primary care. The justification is that in most modern healthcare systems, clinical laboratory settings operate at a high level of reliability and these performance standards are periodically verified as part of external quality accreditation processes.16
The Future of Patient Engagement
Published in Jan Oldenburg, Dave Chase, Kate T. Christensen, Brad Tritle, Engage!, 2020
“…none of the following clinical laboratory test results and any other related results shall be conveyed to a patient by Internet posting or other electronic means: HIV antibody test.Presence of antigens indicating a hepatitis infection.Abusing the use of drugs.Test results related to routinely processed tissues, including skin biopsies, Pap smear tests, products of conception, and bone marrow aspirations for morphological evaluation, if they reveal a malignancy.”48
Medicine, Technology and Industry
Published in Roger Cooter, John Pickstone, Medicine in the Twentieth Century, 2020
Throughout this time clinical laboratory testing, and its costs, rose inexorably. Numbers of tests (for example in the area of prenatal care) were rising rapidly, and the market for clinical chemistry equipment was beginning to look attractive. Within five years some thirty automatic or semi-automatic systems were developed worldwide. Of these, Union Carbide’s ‘Centrifichem’ system (based on technology developed at the Oak Ridge National Laboratory, which was managed by Union Carbide) was Technicon’s major competitor. Dow Coming and DuPont were two other major corporations which entered this field. The industry had grown and become intensely competitive. Technicon, which had grown from a small family business into a multimillion dollar corporation, was subsequently taken over by a still larger firm (Revlon).
Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 versus reference tocilizumab: a randomized, double-blind, single-dose phase I study
Published in Expert Opinion on Investigational Drugs, 2023
Kyung-Sang Yu, Byungwook Kim, Dongseong Shin, Min Kyu Park, Jun Gi Hwang, Min-Gul Kim, Hyewon Chung, JongLyul Ghim, Jae-Yong Chung, Josef S. Smolen, Gerd R. Burmester, SungHyun Kim, YunJu Bae, DaBee Jeon, JaeKyoung Yoo, GoEun Yang, JiHun Bae, Edward Keystone
Safety assessments included monitoring of adverse events (AEs), hypersensitivity, and prior/concomitant medications throughout the study. Clinical laboratory assessments (hematology, clinical chemistry, and urinalysis) were conducted during screening (Day −28 to −2), at Days −1, 2, 6, 13, 29, and EOS. Treatment-emergent adverse events (TEAEs) were AEs that occurred or worsened after study drug exposure. Treatment-emergent adverse events of special interest (TEAESIs) were infection, hypersensitivity (including anaphylaxis), injection-site reactions (ISRs), hepatic events, hemorrhage, gastrointestinal perforation, malignancy, and demyelinating disorders (see Supplementary Methods). TEAEs were coded using the Medical Dictionary for Regulatory Activities version 25.0. Severity was graded using the Common Terminology Criteria for Adverse Events version 5.0. Local injection-site pain was measured within 15 min after study drug administration using a 100-mm visual analog scale (VAS).
Lean and Six Sigma as continuous quality improvement frameworks in the clinical diagnostic laboratory
Published in Critical Reviews in Clinical Laboratory Sciences, 2023
Vinita Thakur, Olatunji Anthony Akerele, Edward Randell
Studies examining the operation of CPI initiatives in the clinical laboratory are scarce. It is important for a clinical laboratory to focus on all aspects of the testing process, from the decision to test, to reporting and the interpretation of reports, not only to achieve high analytical quality but also to provide downstream value. Approximately 61.9–68.2% of errors occur in the pre-analytical phase, 13.3–15% in the analytical phase, and 18.5–23.1% in the post-analytical phase [38,39]. One reason for the high rates of pre-analytical and post-analytical errors may be at least partially related to the disconnect between laboratories and other clinical services and the lack of communication between them. Not surprisingly, most laboratory errors occur either before or after the test is performed [40], with as many as 46–68.2% and 25–45.5% of errors occurring at the pre–pre-analytical and the post-post analytical phases, respectively [41]. Laboratory results may not contain all the information that is relevant to the clinician or may contain information that the clinician considers unimportant. Also, not all errors occurring in the laboratory impact patients. The rate of laboratory errors depends on the methods used to detect errors: the closer one looks, the greater likelihood of detecting errors [40].
Budget impact of capmatinib for adults with metastatic non-small cell lung cancer harboring a MET exon 14 skipping mutation in the United States
Published in Journal of Medical Economics, 2021
Beilei Cai, Zheng-Yi Zhou, Weiguang Xue, Nisha C. Hazra, Mukesh Singh, Dinesh Mishra, Diana Brixner, Gary Oderda, Joseph Biskupiak
The model assumed that next-generation sequencing (NGS) is used for all METex14 mutation testing. The total annual testing costs were calculated using the unit costs of testing and the proportion of treatment-naïve and previously treated patients tested in each year in the model. Medicare testing costs were obtained from the CMS Clinical Laboratory Fee Schedule28 and commercial testing costs were assumed from published literature33,34. The NGS testing cost was assumed to be $6,068.79 (average cost of commercially available NGS testing of >50 genes) for the commercial perspective34 and $1,758.76 for the Medicare perspective28. The model also assumed that testing for PD-L1 was performed in 75% of patients35, and the unit costs of PD-L1 testing were assumed to be $267.23 (commercial) and $127.40 (Medicare)25. Other mutation testing costs were not explicitly considered in the model.