36-851.03. Procurement organizations; requirements; records; rules; inspection

A. Except as provided in section 36-851.02, each procurement organization that is required to be licensed pursuant to section 36-851.01 shall do all of the following:

1. Designate a medical director who is a physician licensed pursuant to title 32, chapter 13 or 17 and who provides medical guidance to determine donor eligibility.

2. Employ a director who holds at least a bachelor's degree in a related science from an accredited university and who is responsible for all licensed activities of the organization.

3. Comply with all of the following as adopted in rule by the department of health services:

(a) The proper use and maintenance of donor consent forms.

(b) The implementation and maintenance of proper identification systems for bodies and disarticulated items.

(c) The implementation and maintenance of protocols and materials for procedures used by the procurement organization to properly screen end users.

(d) The proper documentation and disclosure of the disease status of tissue specimens to end users.

(e) Labeling, packaging, transport and distribution policies and procedures.

(f) Final disposition procedures.

4. Implement and maintain all of the following:

(a) Standard operating procedures for all licensed functions of the organization.

(b) A safety awareness and blood-borne pathogen training program that complies with state and federal law.

(c) A cleaning program that mitigates potential cross-contamination between donors.

5. Provide a designated area for tissue recovery that:

(a) Is open to inspection by the department of health services with or without notice.

(b) Does not operate in a funeral establishment for the recovery of whole bodies for medical research and education.

6. Properly track donors and label tissue by doing both of the following:

(a) Assigning a unique identifying number to each donor and using this number for all tissue from that donor that is recovered and distributed.

(b) Affixing labels with the following information on all nontransplant tissue specimens:

(i) A statement that universal precautions will be used.

(ii) A statement that the specimen is not for transplant or clinical use.

(iii) Any condition or limitation regarding the use of the specimen.

(iv) Contact information for the procurement organization.

7. Maintain the following records for ten years after the last date of tissue distribution:

(a) A copy or recorded consent of the donation authorization.

(b) A copy of the donor's death certificate and transit permit issued by the state where the death occurred.

(c) A copy of the donor's physical assessment and risk assessment questionnaire.

(d) A copy of the donor's serological results, when applicable.

(e) A copy of all documentation relating to tissue recovery, storage and distribution activities.

B. The department of health services shall adopt rules that follow, as nearly as practicable, the requirements on equivalent subjects specified in subsection A of this section that are set forth in the accreditation requirements of a nationally recognized accrediting agency that is approved by the department.

C. A procurement organization that is subject to the requirements of this section is subject to inspection by the department of health services at any time to evaluate the compliance by the procurement organization with the requirements of this article and the rules adopted by the department.