3701-83-47 Radiation safety standards - freestanding radiation therapy centers.

 

3701-83-47                  Radiation safety standards.

 

 

 

(A)   Each freestanding radiation therapy center shall maintain and follow written policies and procedures for the handling of emergencies which may threaten the health and safety of patients, staff and public.

 

(B)      Each freestanding radiation therapy center shall comply with the applicable provisions of Chapter 3748. of the Revised Code and the rules adopted pursuant to that Chapter.

 

(C)   Each freestanding radiation therapy center shall identify, document, and report to the department incidents in which equipment malfunction contributed or may have contributed to patient injury or death.

 

(D)Each freestanding radiation therapy center shall report the following incidentsin the manner described below to the director:

 

(1)All instances of treatment of the wrong subject, wrong treatment site,or wrong modality of treatment;

 

(2)When the treatment consists of three or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than ten per cent of the total prescribed dose;

 

(3)When the treatment consists of more than three fractions and the calculated total administered dose differs from the total prescribed dose by more than twenty per cent of the total prescribed dose;

 

(4)Nonelective admission to the hospital as a result of treatment during or within thirty days of completion of course of treatment.

 

(E)Each incident as described in paragraph (C) and (D) of this rule shall be reported to the director by telephone no later than the next calendar day, and by letter within fifteen days after the incident occurred. Each incident shall also be reported to the patient and the referring physician within twenty-four hours of the occurrence of the incident. The letter shall identify the facility's name and address; a brief description of the event; why the event occurred; the effect on the patient; what improvements are needed to prevent recurrence; and actions taken to prevent recurrence. The letter shall be sent to:

 

"Director of Health, Ohio Department of Health, Bureau of Radiation Protection,

 

 

 

3701-83-47                                                                                                                            2

P.O.Box 118 Columbus, OH 43266-0118"

Effective:                                9/5/2002

R.C. 119.032 review dates:    2/28/2002 and 02/28/2006

CERTIFIED ELECTRONICALLY

Certification

08/26/2002 03:50 PM

Date

Promulgated Under:   119.03

Statutory Authority:   3702.13, 3702.30

Rule Amplifies:           3702.12, 3702.13, 3702.30

Prior Effective Dates: 1/13/96