R9-9A-303. Security Standards; Inventory Controls

A. A licensee of a non-accredited procurement organization shall ensure that access to the enclosed-locked areas where non- transplant anatomical donations and non-transplant anatomical material are located is limited to individuals authorized by the licensee or administrator. B. An administrator of a non-accredited procurement organization shall ensure that: 1. Standard operating procedures are developed, documented, and maintained to prevent unauthorized access to non-transplant anatomical donation or non-transplant anatomical material inventory that: a. Restricts access to the areas of the building that contain non-transplant anatomical donations or non- transplant anatomical material inventory and donor records, b. Provides for identification of authorized individuals, and c. Specifies the methods for conducting electronic monitoring; 2. Personnel or security equipment to deter and prevent unauthorized entrance into limited access areas are present and operational and include: a. Devices or a series of devices to detect unauthorized intrusion, which may include a signal system interconnected with a radio-frequency device or other mechanical or electronic devices; b. Exterior lighting to facilitate surveillance; and c. Electronic monitoring using video cameras to provide coverage of: i. Entrances to and exits from limited access areas, and ii. Entrances to and exits from the buildings; 3. Video recordings from the video cameras required in subsection (B)(2)(c) are retained for at least 30 calendar days; 4. The electronic monitoring system in subsection (B)(2)(c) has a failure notification system that provides an audible and visual notification of any failure in the electronic monitoring system; and 5. Battery backup is present and operational to ensure the functioning of video cameras and recording equipment in the event of a power outage. C. A licensee of a non-accredited procurement organization shall establish and implement an inventory tracking system for non- transplant anatomical donations and non-transplant anatomical material that: 1. Contains information about all non-transplant anatomical donations received and non-transplant anatomical material released for distribution; 2. Includes release documentation related to requirements in R9-9A-201(B), and R9-9A-203(C) and (K), for each item of non-transplant anatomical material prior to transferring the item of non-transplant anatomical material to inventory; 3. Documents the date, time, and location for non-transplant anatomical material transferred for use, including: a. The name of the individual performing the transfer, and b. The name and contact information for an end-user or other person to which non-transplant anatomical material may be transferred; 4. Documents the date, time, and location for items of non- transplant anatomical material that are moved between locations controlled by the procurement organization, including the name of the individual overseeing the move; and 5. Ensures non-transplant anatomical material that can no longer be used is removed from inventory and disposed of according to applicable standard operating procedures for final disposition.