Ohio Admin. Code 3701:1-58-105 - Report and notification for an eluate exceeding permissible molybdenum-99, strontium-82, and strontium-85 concentrations
(A)
The licensee
shall notify by telephone the department at 614-644-2727 and the distributor of
the generator within seven calendar days after discovery that an eluate
exceeded the permissible concentration listed in paragraph (A) of rule
3701:1-58-35
of the Administrative Code at the time of generator elution. The telephone
report to the department must include the manufacturer, model number, and
serial number (or lot number) of the generator; the results of the measurement;
the date of the measurement; whether dosages were administered to patients or
human research subjects, when the distributor was notified, and the action
taken.
(B)
By an appropriate method listed in rule
3701:1-40-04 of
the Administrative Code, the licensee shall submit a written report to the
department within thirty calendar days after discovery of an eluate exceeding
the permissible concentration at the time of generator elution. The written
report must include the action taken by the licensee; the patient dose
assessment; the methodology used to make this dose assessment if the eluate was
administered to patients or human research subjects; and the probable cause and
an assessment of failure in the licensee's equipment, procedures or training
that contributed to the excessive readings if an error occurred in the
licensee's breakthrough determination; and the information in the telephone
report as required by paragraph (A) of this rule.
Notes
Promulgated Under: 119.03
Statutory Authority: 3748.02, 3748.04
Rule Amplifies: 3748.04
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