LAC 46:LIII.1211. Documentation

A. Documentation as to type of equipment, serial number, content, policies and procedures and location shall be maintained in the pharmacy for review by the board. Such documentation shall include, but is not limited to: 1. name, address, and permit number of the pharmacy and the location where the system is operational; 2. manufacturer’s name and model; 3. quality assurance policies and procedures to determine continued appropriate use and performance of the system; 4. policies and procedures for system operation, safety, security, accuracy, patient confidentiality, access, controlled substances, data retention, definitions, downtime procedures, emergency or first dose procedures, inspection, installation requirements, maintenance security, quality assurance, medication inventory, staff education and training, system set-up, and malfunction procedures; and 5. security procedures sufficient to prevent unauthorized access or use, prevent the illegal use or disclosure of protected health information, and comply with any applicable federal or state regulations. B. A current copy of all pharmacy policies and procedures related to the use of the system shall be maintained at all locations where the system is being used.