A commonly encountered challenge with freeze-dried drug products is glass vial fogging. Fogging is characterized by a thin layer of product deposited upon the inner surface of the vial above the lyophilized cake. While considered to be a routine cosmetic defect in many instances, fogging around the shoulder and neck of the vial may potentially impact container closure integrity and reject rates during inspection.
View Article and Find Full Text PDFIntroduction: Healthcare organizations faced unique operational challenges during the COVID-19 pandemic. Assuring the safety of both patients and healthcare workers in hospitals has been the primary focus during the COVID-19 pandemic.
Methods: The NIH Vaccine Program (VP) with the Vaccine Management System (VMS) was created based on the commitment of NIH leadership, program leadership, the development team, and the program team; defining Key Performance Indicators (KPIs) of the VP and the VMS; and the NIH Clinical Center's (NIH CC) interdisciplinary approach to deploying the VMS.
With the enactment of the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009, hospitals and physician practices across the country converted from a system of paper recordkeeping to fully integrated electronic health records (EHR)., With financial incentives in hand, there was a rush to market to acquire and implement these systems. Fast-forward 10 years, and it is apparent that the EHR space has significantly evolved in technology, processes, and policies.
View Article and Find Full Text PDFPerspect Health Inf Manag
January 2022
An information technology governance (ITG) program has helped the National Institutes of Health (NIH) Clinical Center (CC) in the implementation of many systems and has guided the organization through the maturity of its project management methodology. The NIHCC Department of Clinical Research Informatics (DCRI) maintains an electronic health record (EHR) called the clinical research information system (CRIS) along with many clinical information systems (CIS) and research information systems, supporting approximately 3,200 users. ITG involves establishing processes to guide the review, selection, implementation, management, and setting of the IT strategy representing the business owners, stakeholders, and IT.
View Article and Find Full Text PDFInfect Control Hosp Epidemiol
November 2022
Voluntary asymptomatic severe acute respiratory coronavirus virus 2 (SARS-CoV-2) testing was provided by the NIH Clinical Center over 1 year. Among 105,927 tests, 0.2% were positive.
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