SECTION 310:505-5-9. Annual report

(a)   Each tissue bank in Oklahoma shall prepare and submit an annual report to the Department based on the previous calendar year's twelve month period of January 1st through December 31st.

(b)   Annual reports shall be provided to the Department by March 31st of each calendar year.

(c)   During a tissue bank's first year of operation, the annual report shall be based on the period from the first day of operation to December 31st of that year.

(d)   Each annual report shall include at least the following information:

(1)   The accreditation status of the tissue bank;

(2)   A report of all regulatory, accreditation, or internal inspections which result in findings that impact the quality of the product or services provided by the tissue bank;

(3)   The names and certification statuses of all technical personnel who meet the requirements of OAC 310:505-5-7.

(4)   The name and qualifications of the current medical director including evidence the medical director is currently licensed to practice medicine in Oklahoma;

(5)   The type and geographic origins of all donor tissue procured; and

(6)   The number and types of units of processed tissue used for patients in the service area of the tissue bank.

[Source: Added at 18 Ok Reg 1711, eff 5-25-01]