LuxaCrown (US) On 9/1 Sonja email Rob, the initial documentation to commence LuxaCrown dossier, (e.g. preliminary IFU, Labels, Risk Analysis, Declaration of Conformity, Clinical Evaluation, Product specifications, SDS, Flyer and Quality control report along with supporting documents STED) On 9/1 Rob email Sonja, requesting further information as well as the contact name, title and email for the DMG contact associated with the manufacturer (See attached Rob’s full email request) On 9/14 Sonja email Rob, letting him know that they won’t have the requested documents available for about 6 weeks (see attached Sonja’s full email) Ecosite Bulk Fill (US) On 9/28 Deborah email Elizabeth (me), that additional testing has been initiated at DMG and
Hope this email helps, please do not hesitate to contact us if we can be of any further assistance.
Napalya Boyd with DHR was notifed and was advised how to get a copy of this report.
In this situation, honesty about testing and possible results should have been discussed with the patient and an informed, realistic action should have been explained. The next step would be to evaluate the relationship with the patient and her parents and encouragement of an open and honest relationship. If the patient were to continue to decide that the notification of the parents was out of question then resources to discuss the results of the testing with the patient's parents would have been an alternative. Care providers should guide care that is respectful of the individual, offer alternatives, provide concrete facts related to the care needs, and offer support systems that will aid in the making positive choices. The application of this framework allows the patients to experience the greater good with no harm. It provides a clear framework that fosters openness and honesty between the patient and the care providers.
I will continue to monitor and please share with me any additional information you may
On Thursday, January 12, 2017, this writer along with Investigator Hopkins responded to United Medical Center to ascertain if M-1 was there negative results. A flier of M-1 was left with register nurse Akinyode at 1712 hours.
CM Gilmore contacted Terri Mohn who, is a relative of Crystal Mohn. Terri provide the following:
On 04/28/2016 at 1603 hours I was contacted by Tracy King on the TRC SRO cell phone and asked to come to her office. Upon arrival King informed me if an email she had been forwarded from another faculty member Andrew Rivetti.
If you have any questions regarding the attachments please don’t hesitate to reach out to me via email or my cell phone 203-751-1340.
It is accurate that the last sentence of the first paragraph of your report you stated “This evaluation was requested for diagnostic clarification and treatment planning”?
Call Randall Lowey and speak with him about the concern of Shyann’s diabetes and see who monitors her diabetes.- CW Holland made a home visit , but he was not at home to completed this task
This stage is when the patient first hears about his/her illness, and this is where the patient is saying "no, not me" and "it can't be me". During this time they will also ask a numerous amount that "is the results wrong", or "could you check my results again please".
From the original collection of samples to the final step of communicating the test results to the patients, LAA has shown that they have created a process with numerous factors to success as well as room for improvement. The following is a flow chart representative of the steps of the process and the reliance each step has to other steps:
I’ve worked in the Human Resources (HR) department for my institution prior to my current role. I admire your teams approach to addressing the departmental issue with reporting what would seem to be invalid data. I’m curious to know when the “voice” component came into play with this value conflict situation. I would assume that if this request was being submitted to your supervisor to be reviewed and “fixed”, that at some point there is a possibility that this request had been granted on a previous occasion. If this is the case than it really took some courage for someone to question the ethicalness of doing this. Or was this a concern that gained support from everyone as a group before anything was done?
on the Vigilance project. The message was sent under his name and that of his deputy director, Francine D’Aubigne, who was located in France. The e-mail message was a surprise to Vigilance team members, and to others throughout the Drug