12 Va. Admin. Code § 5-481-3410 - Quality management program
Each
A. Scope and applicability. The quality
management program shall address, at a minimum, the following specific
objectives:
1. Written directives.
a. A written directive shall be dated and
signed by an authorized user prior to the administration of radiation. If
because of the patient's condition a delay caused by providing a written
revision to an existing written directive would jeopardize the patient's
health, an oral revision to an existing written directive will be acceptable,
provided that the oral revision is documented as soon as possible in writing in
the patient's record and a revised written directive is signed by an authorized
user within 48 hours of the oral revision.
b. The written directive shall contain the
patient 's or human research subject's name, type and energy of the beam, total
dose , dose per fraction, treatment site, and number of fractions.
c. 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 the administration of the therapeutic radiation
machine dose or the next fractional dose.
d. The registrant shall retain a copy of the
written directive for three years.
2. Procedures for administrations. The
registrant shall develop, implement, and maintain written procedures to provide
high confidence that:
a. Prior to the
administration of each course of radiation treatment, the patient 's or human
research subject's identity is verified by more than one method as the
individual named in the written directive;
b. Each administration is in accordance with
the written directive ;
c.
Therapeutic radiation machine final plans of treatment and related calculations
are in accordance with the respective written directives by:
(1) Checking both manual and
computer-generated dose calculations to verify they are correct and in
accordance with the written directive; and
(2) Verifying that any computer-generated
calculations are correctly transferred into the consoles of authorized
therapeutic medical units;
d. Any unintended deviation from the written
directive is identified and evaluated, and appropriate action is taken;
and
e. The registrant retains a
copy of the procedures for administrations for the duration of the
registration.
B. Reports and notifications of
misadministrations.
1. A registrant shall
report any event resulting from the treatment of a patient or human research
subject in which the administration of therapeutic radiation machine radiation
results, or will result in, unintended permanent functional damage to an organ
or a physiological system as determined by a physician.
2. Other than events that result from the
treatment of a patient or human research subject, a registrant shall report any
event in which the administration of a therapeutic radiation machine therapy
dose :
a. Involves the wrong patient , wrong
treatment modality, or wrong treatment site;
b. The calculated weekly administered dose
differs from the weekly prescribed dose by more than 30%; or
c. The calculated total administered dose
differs from the total prescribed dose by more than 20% of the total prescribed
dose .
3. The registrant
shall notify the agency by telephone no later than the next calendar day after
the discovery of a misadministration.
4. The registrant shall submit a written
report to the agency within 15 days after the discovery of a misadministration.
The written report shall include:
a. The
registrant 's name;
b. The name of
the prescribing physician ;
c. A
brief description of the event;
d.
Why the event occurred;
e. The
effect, if any, on the individual who received the misadministration;
f. Actions, if any, that have been taken or
are planned to prevent recurrence; and
g. Certification that the registrant notified
the individual, or the individual's responsible relative or guardian, and if
not, why not.
5. The
report shall not contain the individual's name or any other information that
could lead to the identification of the individual.
6. The registrant shall provide notification
of the event to the referring physician and also notify the individual who is
the subject of the misadministration no later than 24 hours after its
discovery, unless the referring physician personally informs the registrant
either that he will inform the individual or that, based on medical judgment,
telling the individual would be harmful. The registrant is not required to
notify the individual without first consulting the referring physician . If the
referring physician or the affected individual cannot be reached within 24
hours, the registrant shall notify the individual as soon as possible
thereafter. The registrant may not delay any appropriate medical care for the
individual, including any necessary remedial care as a result of the
misadministration, because of any delay in notification. To meet the
requirements of this subdivision, the notification of the individual who is the
subject of the misadministration may be made instead to that individual's
responsible relative or guardian. If a verbal notification is made, the
registrant shall inform the individual, or appropriate responsible relative or
guardian, that a written description of the event can be obtained from the
registrant upon request. The registrant shall provide such a written
description if requested.
7. Aside
from the notification requirement, nothing in this section affects any rights
or duties of registrants and physicians in relation to each other, to
individuals affected by the misadministration, or to that individual's
responsible relatives or guardians.
8. The registrant shall retain a record of a
misadministration in accordance with subsection C of this section. A copy of
the required record shall be provided to the referring physician if other than
the registrant within 15 days after discovery of the
misadministration.
C.
Records of misadministrations. A registrant shall retain a record of
misadministrations reported in accordance with subsection B of this section for
three years. The record shall contain the following:
1. The registrant 's name and the names of the
individuals involved;
2. The social
security number or other identification number, if one has been assigned, of
the individual who is the subject of the misadministration;
3. A brief description of the event; why it
occurred; and the effect, if any, on the individual;
4. The actions, if any, taken or planned to
prevent recurrence; and
5. Whether
the registrant notified the individual, or the individual's responsible
relative or guardian and, if not, whether such failure to notify was based on
guidance from the referring physician .
Notes
Statutory Authority: §§ 32.1-12 and 32.1-229 of the Code of Virginia.
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