Demystifying Fogging in Lyophilized Products: Impact of Pharmaceutical Processing.

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.

Establishing a Health Information Technology for the Vaccination of National Institutes of Health Staff.

Introduction: 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.

Are You Using the Right Electronic Health Record?

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.

THE EVOLUTION OF INFORMATION TECHNOLOGY GOVERNANCE AT THE NIH CLINICAL CENTER.

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.

Experience with voluntary severe acute respiratory coronavirus virus 2 (SARS-CoV-2) testing of asymptomatic staff at the National Institutes of Health for one year.

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.

Intramuscular progesterone optimizes live birth from programmed frozen embryo transfer: a randomized clinical trial.

Objective: To determine whether vaginal progesterone for programmed endometrial preparation is noninferior to intramuscular progesterone in terms of live birth rates from frozen embryo transfer (FET).

Design: Three-armed, randomized, controlled noninferiority trial.

Setting: Multicenter fertility clinic.

Unveiling the silent threat among us: leveraging health information technology in the search for asymptomatic COVID 19 healthcare workers.

Assuring the safety of both patients and healthcare workers (HCWs) in hospitals has been the primary focus of every healthcare organization during the COVID 19 pandemic. This article discusses the NIH Clinical Center's interdisciplinary approach to deploying an organizational Asymptomatic Staff Testing System.

Vitrified blastocyst transfer cycles with the use of only vaginal progesterone replacement with Endometrin have inferior ongoing pregnancy rates: results from the planned interim analysis of a three-arm randomized controlled noninferiority trial.

Objective: To assess the noninferiority of vaginal P (Endometrin) compared with daily intramuscular P for replacement in programmed vitrified-warmed blastocyst transfer cycles and to assess the noninferiority of vaginal P in combination with intramuscular progesterone every third day compared with daily intramuscular P.

Design: Three-arm randomized controlled noninferiority study. To enable early recognition of inferiority if present, an a priori interim analysis was planned and completed once ongoing pregnancy data were available for 50% of the total enrollment goal.

Pharmacogenomics Implementation at the National Institutes of Health Clinical Center.

The National Institutes of Health Clinical Center (NIH CC) is the largest hospital in the United States devoted entirely to clinical research, with a highly diverse spectrum of patients. Patient safety and clinical quality are major goals of the hospital, and therapy is often complicated by multiple cotherapies and comorbidities. To this end, we implemented a pharmacogenomics program in 2 phases.

Integrating pharmacogenetic information and clinical decision support into the electronic health record.

Pharmacogenetics (PG) examines gene variations for drug disposition, response, or toxicity. At the National Institutes of Health Clinical Center (NIH CC), a multidepartment Pharmacogenetics Testing Implementation Committee (PGTIC) was established to develop clinical decision support (CDS) algorithms for abacavir, carbamazepine, and allopurinol, medications for which human leukocyte antigen (HLA) variants predict severe hypersensitivity reactions. Providing PG CDS in the electronic health record (EHR) during order entry could prevent adverse drug events.

Interpreting nurses' responses to clinical documentation alerts.

Objective: To understand how nurses respond to alerts that detect attempts to enter into electronic health records patient weights that vary significantly from previously recorded weights.

Methods: Examination of subsequent patient weights to determine if the alerts were true positive (TP) or false positive (FP), and whether nurses overrode alerts, changed their entry or quit without storing a value.

Results: Alerts occurred 2.

Use of F 18-fluoro-D-glucose-positron emission tomography-computed tomography to localize a hilar cell tumor of the ovary.

Objective: To describe provocative testing and alternative imaging strategies used to localize an androgen-producing tumor in a 58-year-old woman with severe hirsutism.

Design: Case report.

Setting: Clinical Research Center.

Use of clinical alerting to improve the collection of clinical research data.

Data errors in electronic health records have been shown to have the potential to adversely impact the conclusions drawn from clinical research. We prospectively studied the efficacy of a new alert to infer errors in previously stored data and to decrease the frequency of data entry errors, in an attempt to improve the quality of data for clinical trials. For the purpose of this study, we monitored data entry errors in height or weight measurements.

Embryo afterloading: a refinement in embryo transfer technique that may increase clinical pregnancy.

Objective: Given the importance of ET technique during assisted reproductive technology cycles, we evaluated the effect of embryo afterloading subsequent to placement of the ET catheter on pregnancy rates vs. a standard direct ET.

Design: Retrospective cohort analysis.

Anthrax vaccine does not affect semen parameters, embryo quality, or pregnancy outcome in couples with a vaccinated male military service member.

Anthrax vaccination has been used in an effort to prevent infection should anthrax be used as a biological weapon, and widespread use has been considered in the event of another anthrax attack on American soil, but the long-term impact of anthrax vaccination on reproductive outcome is unknown. We found that exposure to the anthrax vaccine by males who were undergoing assisted reproduction did not negatively impact semen parameters, fertilization rate, embryo quality, or clinical pregnancy rates.

A suboptimal endometrial pattern is associated with a reduced likelihood of pregnancy after a day 5 embryo transfer.

This retrospective study examined the association of endometrial pattern and pregnancy after a day 5 ET. The pregnancy rate of women with a triple-line ultrasound endometrial pattern on the day of hCG administration was significantly higher than the pregnancy rate of women with the other ultrasound patterns. This observation suggests that, in a subset of patients, a suboptimal endometrial lining may interfere with assisted reproductive technology success.

Multiple leiomyomas of the esophagus, lung, and uterus in multiple endocrine neoplasia type 1.

Multiple endocrine neoplasia type 1 (MEN1) is an autosomal dominant hereditary disorder characterized by multiple parathyroid, pancreatic, duodenal, and pituitary neuroendocrine tumors. Nonendocrine mesenchymal tumors, such as lipomas, collagenomas, and angiofibromas have also been reported. MEN1-associated neuroendocrine and some mesenchymal tumors have documented MEN1 gene alterations on chromosome 11q13.

Evolution of SACRED (staff authority credentialing): an automated credentialing system.

Over a period of 5 years, the medical record department (MRD) at the Warren G. Magnuson Clinical Center of the National Institutes of Health developed and refined a customized medical staff credentialing system. The result is SACRED, an automated credentialing system that supports the changing requirements of the credentialing process and continues to meet the needs of its customers.