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

Universal Citation: SC Code Regs 61-64.I.RHB 1.11

Current through Register Vol. 48, No. 9, September 27, 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.

1.11.2 Diagnostic Misadministrations. When a misadministration involves a diagnostic procedure, the registrant shall promptly investigate its cause, make a record for Departmental review, and maintain the record for three (3) years. The record shall contain the names of all individuals involved in the event (including the prescribing physician, allied health personnel, and the patient's referring physician), a brief description of the misadministration, the effect on the patient, what improvements are needed to prevent recurrence, and the actions taken to prevent recurrence.

1.11.3 Aside from the notification requirement, nothing in RHB 1.11.1 through 1.11.2 shall affect any rights or duties of registrants and physicians in relation to each other, registrants, patients, or responsible relatives or guardians.

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