CMIS 4302 Patient Records Practice and Policy Paper
For this Application, assume that you have been asked to be a business consultant to a new medical practice (LA Healthcare Associates, LLC) containing one physician, one nurse and two office staff. They are going to use an India-based billing company and a Philippines-based transcription company. LA Healthcare Associates are not sure about the kinds of documents they need to deploy internally or with their vendors. They are also looking for guidance concerning HIPAA.
Gather together five business-related documents for this practice. Populate them with the company name, create a business address, and create fictitious profiles for the four employees of the practice (referenced above), and for the offshore entities.
Clinical Research FDA Audit Worksheet
You are the manager of a clinical research site, and you were just informed that your site has been selected for a routine FDA audit in a week.
Please outline the steps your site should perform to ensure you are inspection ready. If the sponsor personnel are relevant feel free to include but ensure you specify their roles and responsibilities.
Please include the roles and responsibilities of each staff member involved in the preparation. Please ensure you include the departments that you should inform, e.g. IRB. FYI, there may be other departments too.
Must be in a checklist format: responsible persons and task/activities and must include at least 15 tasks and include the contents of the regulatory binder. Please be thorough and ensure you cover all steps and departments. Do not include a narrative on the importance and purpose of audits as this is not part of the assignment. You will only be graded on a checklist. In addition, make it your own, be creative, and do not copy one from the internet. Instructor will be scrutinizing the Turnitin scores
Checklist Format: use EXCEL with All of the following Columns: Task, Responsible Party, Completion Date, Finding and Comments
Roles and Responsibilities
Organization and relevance of the activities: