Current through February, 2024
(a) Each applicant
or licensee subject to section 11-45-236 or section 11-45-238 shall establish
and maintain a written quality management program to provide high confidence
that radiation shall be administered as directed by the authorized user. The
quality management program shall include written policies and procedures to
meet the following specific objectives:
(1)
Before administration, a written directive is prepared for any external beam
radiation therapy dose;
(A) Notwithstanding
this paragraph, a written revision to an existing written directive may be made
provided that the revision is dated and signed by an authorized user before the
administration of the external beam radiation therapy dose or the next external
beam radiation therapy fractional dose;
(B) Notwithstanding this paragraph, 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
forty-eight hours of the oral revision;
(C) Notwithstanding this paragraph, 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 twenty-four hours
of the oral directive.
(2) Before the administration of each course
of radiation treatments, the patient's identity is verified, by more than one
method, as the individual named in the written directive;
(3) External beam radiation therapy final
plans of treatment and related calculations are in accordance with the
respective written directives;
(4)
Each administration is in accordance with the written directive; and
(5) Any unintended deviation from the written
directive is identified and evaluated, and appropriate action is
taken.
(c) Development
of quality management program.
(1) Each
application for a license subject to section 11-45-236 or section 11-45-238
shall develop a quality management program as part of the application required
by subchapter 2. The licensee shall implement the program upon issuance of a
license by the department;
(2) Each
existing licensee subject to sections 11-45-236 and 11-45-238 shall, within
thirty days of the effective date of this chapter, submit to the department a
written certification that a quality management program has been
implemented.
(d) As a
part of the quality management program, the licensee shall:
(1) 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, all
recordable events, and all misadministrations to verify compliance with all
aspects of the quality management program;
(2) Conducted these reviews at intervals not
to exceed twelve months;
(3)
Evaluate each of these reviews to determine the effectiveness of the quality
management program and, if required, make modifications to meet the
requirements of subsection (b); and
(4) Maintain records of each review,
including the evaluations and findings of the review.
(e) The licensee shall evaluate and respond,
within thirty days after discovery of the recordable event, to each recordable
event by:
(1) Assembling the relevant facts
including the cause;
(2)
Identifying what, if any, corrective action is required to prevent recurrence;
and
(3) Retaining a record, in an
auditable form, of the relevant facts and what corrective action, if any, was
taken.
(f) The licensee
shall retain:
(1) Each written directive;
and
(2) A record of each
administered radiation dose, in an auditable form.
(g) The licensee may make modifications to
the quality management program to increase the program's efficiency provided
the program's effectiveness is not decreased.
(h) The licensee shall evaluate each
misadministration and shall take the following actions in response to a
misadministration:
(1) Notify the department
by telephone no later than the next calendar day after discovery of the
misadministration;
(2) Submit a
written report to the department within fifteen days after discovery of the
misadministration. The written report shall include: the licensee'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 licensee notified
the patient or the patient's responsible relative or guardian (this person
shall 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;
(3) Notify the referring physician and also
notify the patient of the misadministration no later than twenty-four hours
after its discovery, unless the referring physician personally informs the
licensee either that he/she shall inform the patient or that, based on medical
judgment, telling the patient would be harmful. The licensee 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 hours, the
licensee shall notify the patient as soon as possible thereafter. The licensee
shall 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;
(4) Retain a
record of each misadministration. The record shall contain the names of all
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
(5) If the
patient was notified, furnish, within fifteen 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 department, 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 department can be
obtained from the licensee;
(i) Aside from the notification requirement,
nothing in subsection (h) affects any rights or duties of licensees and
physicians in relation to each other, patients, or the patient's responsible
relatives or guardians.