South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part I - GENERAL PROVISIONS › Section 61-64.I.RHB 1.11 - Records and Reports of Misadministration

Current through Register Vol. 48, No. 6, June 28, 2024
1.11.1 Therapy Misadministrations.
When a misadministration involves any therapy procedure, the
				  registrant shall notify the Department, by a means as determined by the
				  Department, no later than twenty-four (24) hours after discovery of the
				  misadministration. The registrant shall also notify the referring physician and
				  the patient of the misadministration no later than twenty-four (24) hours after
				  its discovery, unless the referring physician personally informs the registrant
				  that he or she will inform the patient or that, based on medical judgment,
				  telling the patient would be harmful. The registrant is not required to notify
				  the patient without first consulting the referring physician. If the referring
				  physician or patient cannot be reached within twenty-four (24) hours, the
				  registrant shall notify the patient as soon as possible thereafter. The
				  registrant may not delay any appropriate medical care for the patient,
				  including any necessary remedial care as a result of the misadministration,
				  because of any delay in notification.
1.11.1.1 The registrant shall submit a
				written report to the Department within fifteen (15) calendar days after the
				discovery of the misadministration. The report shall not include the patient's
				name or other information that could lead to identification of the patient. The
				written report shall include the registrant's name; the prescribing physician's
				name; a brief description of the event; why the event occurred; the effect on
				the patient; what improvements are needed to prevent recurrence; the action
				taken to prevent recurrence; whether the registrant notified the patient or the
				patient's responsible relative or guardian; and if not, why the individual
				involved was not informed; and if the patient was notified, what information
				was provided to the patient.
1.11.1.2 The registrant shall furnish the
				following to the patient within fifteen (15) calendar days after discovery of
				the misadministration if the patient was notified:
1.11.1.2.1 A copy of the report that was
				submitted to the Department; or
1.11.1.2.2 A brief description of both the
				event and the consequences, as they may affect the patient, provided a
				statement is included that the report submitted to the Department can be
				obtained from the registrant.
1.11.1.3 Each registrant shall retain a
				record of each therapy misadministration for ten (10) years. The record shall
				contain the names of all individuals involved in the event (including the
				prescribing physician, allied health personnel, the patient, and the patient's
				referring physician), the patient's identification number if one has been
				assigned, a brief description of the event misadministration, the effect on the
				patient, what improvements are needed to prevent recurrence, and the actions
				taken to prevent recurrence.