1. 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.

2. B. An administrator of a non-accredited procurement organization shall ensure that:

   1. 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:

      1. a. Restricts access to the areas of the building that contain non-transplant anatomical donations or non-transplant anatomical material inventory and donor records,
      2. b. Provides for identification of authorized individuals, and
      3. c. Specifies the methods for conducting electronic monitoring;

   2. 2. Personnel or security equipment to deter and prevent unauthorized entrance into limited access areas are present and operational and include:

      1. 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;
      2. b. Exterior lighting to facilitate surveillance; and

      3. c. Electronic monitoring using video cameras to provide coverage of:

         1. i. Entrances to and exits from limited access areas, and
         2. ii. Entrances to and exits from the buildings;
   3. 3. Video recordings from the video cameras required in subsection (B)(2)(c) are retained for at least 30 calendar days;
   4. 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. 5. Battery backup is present and operational to ensure the functioning of video cameras and recording equipment in the event of a power outage.

3. 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. 1. Contains information about all non-transplant anatomical donations received and non-transplant anatomical material released for distribution;
   2. 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. 3. Documents the date, time, and location for non-transplant anatomical material transferred for use, including:

      1. a. The name of the individual performing the transfer, and
      2. b. The name and contact information for an end-user or other person to which non-transplant anatomical material may be transferred;
   4. 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. 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.

Historical Note

R9-9A-303 made under Subchapter A, Article 3, by final expedited rulemaking at 30 A.A.R. 3657 (November 29, 2024), with an immediate effective date of November 5, 2024 (Supp. 24-4).