Current through Bulletin 2024-06, March 15, 2024
(1) In
addition to the definitions in
R313-30-2, the
following definitions are applicable to a quality management program:
"Course" means the entire treatment consisting of multiple
fractions as prescribed in the written directive.
"Misadministration" means the administration of an external
beam radiation therapy dose:
(a)
Involving the wrong patient, wrong treatment modality, or wrong treatment
site;
(b) 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 percent of the total
prescribed dose;
(c) When the
calculated weekly administered dose differs from the weekly prescribed dose by
more than 30 percent; or
(d) When
the calculated total administered dose differs from the total prescribed dose
by more than 20 percent of the total prescribed dose;
"Prescribed dose" means the total dose and dose per fraction
as documented in the written directive.
"Recordable event" means the administration of an external
beam radiation therapy dose when the calculated weekly administered dose
differs by 15 percent or more from the weekly prescribed dose;
"Written directive" means an order in writing for a specific
patient, dated and signed by an authorized user prior to the administration of
radiation, containing the following information: total dose, dose per fraction,
treatment site and overall treatment period.
(2) Scope and Applicability. Applicants or
registrants subject to
R313-30-6
or
R313-30-7
shall establish and maintain a written quality management program to provide
high confidence that radiation will be administered as directed by the
authorized user. The quality management program shall include written policies
and procedures to meet the following specific objectives:
(a) Prior to administration, a written
directive is prepared for an external beam radiation therapy dose;
(i) Notwithstanding R313-30-5(2)(a), a
written revision to an existing written directive may be made provided that the
revision is dated and signed by an authorized user prior to administration of
the external beam radiation therapy dose or the next external beam radiation
therapy fractional dose;
(ii)
Notwithstanding R313-30-5(2)(a), if, because of the patient's condition, a
delay in order to provide a written revision to an existing written directive
would jeopardize the patient's health, an oral revision to an existing written
directive shall be acceptable, provided that the oral revision is documented
immediately in the patient's record and a revised written directive is signed
by an authorized user within 48 hours of the oral revision;
(iii) Notwithstanding R313-30-5(2)(a), if,
because of the emergent nature of the patient's condition, a delay in order to
provide a written directive would jeopardize the patient's health, an oral
directive shall be acceptable, provided that the information contained in the
oral directive is documented immediately in the patient's record and a written
directive is prepared and signed by an authorized user within 24 hours of the
oral directive.
(b)
Prior to the administration of a course of radiation treatments, the patient's
identity is verified, by more than one method, as the individual named in the
written directive;
(c) External
beam radiation therapy final plans of treatment and related calculations are in
accordance with the respective written directives;
(d) An administration is in accordance with
the written directive; and
(e)
Unintended deviations from the written directive is identified and evaluated,
and appropriate action are taken.
(3) Development of Quality Management
Program.
(a) An application for registration
subject to
R313-30-6
or
R313-30-7
shall include a quality management program that specifies staff, duties and
responsibilities, and equipment and procedures as part of the application
required by R313-16 of these rules. The registrant shall implement the program
upon issuance of a Certificate of Registration by the Director;
(b) Existing registrants subject to
R313-30-6
or
R313-30-7
shall submit to the Director a written certification that a quality management
program has been implemented by December 31, 1994.
(4) As a part of the quality management
program, the registrant shall:
(a) Develop
procedures for, and conduct a review of, the quality management program
including, since the last review, an evaluation of a representative sample of
patient administrations, recordable events, and misadministrations to verify
compliance with the quality management program;
(b) Conduct these reviews annually. The
intervals should not exceed 12 months and shall not exceed 13 months;
(c) Evaluate these reviews to determine the
effectiveness of the quality management program and, if required, make
modifications to meet the requirements of R313-30-5(2); and
(d) Maintain records of these reviews,
including the evaluations and findings of the reviews, in a form that can be
readily audited, for three years.
(5) The registrant shall evaluate and
respond, within 30 days after discovery of the recordable event, to recordable
events by:
(a) Assembling the relevant facts
including the cause;
(b)
Identifying what corrective actions are required to prevent recurrence;
and
(c) Retaining a record, in a
form that can be readily audited, for three years, of the relevant facts and
what corrective actions were taken.
(6) The registrant shall retain:
(a) Written directives; and
(b) A record of administered radiation doses,
in a form that can be readily audited, for three years after the date of
administration.
(7) The
registrant may make modifications to the quality management program to increase
the program's efficiency provided the program's effectiveness is not
decreased.
(8) The registrant shall
evaluate misadministrations and shall take the following actions in response to
a misadministration:
(a) Notify the Director
by telephone no later than the next calendar day after discovery of the
misadministration;
(b) Submit a
written report to the Director within 15 days after discovery of the
misadministration. 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; actions taken to prevent recurrence; whether the registrant
notified the patient or the patient's responsible relative or guardian, this
person will subsequently be referred to as "the patient," and if not, why not;
and if the patient was notified, what information was provided to the patient.
The report shall not include the patient's name or other information that could
lead to identification of the patient;
(c) Notify the referring physician and also
notify the patient of the misadministration no later than 24 hours after its
discovery, unless the referring physician personally informs the registrant
either that the physician 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 24 hours, the
registrant shall notify the patient as soon as possible thereafter. The
registrant shall not delay appropriate medical care for the patient, including
necessary remedial care as a result of the misadministration, because of a
delay in notification;
(d) Retain a
record of misadministrations for five years. The record shall contain the names
of individuals involved; including the prescribing physician, allied health
personnel, the patient, and the patient's referring physician; the patient's
social security number or identification number if one has been assigned; a
brief description of the event; why it occurred; the effect on the patient;
what improvements are needed to prevent recurrence; and the actions taken to
prevent recurrence; and
(e) If the
patient was notified, furnish, within 15 days after discovery of the
misadministration, a written report to the patient by sending either a copy of
the report that was submitted to the Director, or a brief description of both
the event and the consequences as they may effect the patient, provided a
statement is included that the report submitted to the Director can be obtained
from the registrant;
(9)
Aside from the notification requirement, nothing in R313-30-5(8) affects the
rights or duties of registrants and physicians in relation to patients, the
patient's responsible relatives or guardians, or to others.