Current through Register 1531, September 27, 2024
(A) A written
directive, as defined in
105 CMR 120.432, must
be dated and signed by an authorized user prior to the administration of
radiation.
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 will be acceptable, provided that the
information contained in the oral directive is documented as soon as possible
in writing in the patient's record and a written directive is prepared within
48 hours of the oral directive.
(B) The written directive must contain the
patient or human research subject's name, the type and energy of the beam, the
total dose, dose per fraction, treatment target volume, and number of
fractions.
(C)
(1) 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 external beam dose, or the
next fractional dose.
If because of the patient's condition, a delay in the 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 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.
(2) The registrant shall retain a copy of the
written directive for three years.
(D)
Procedures for
Administrations of Doses of Radiation. The registrant shall
develop, implement, and maintain written procedures to provide high confidence
that:
(1) Prior to the administration of each
course of radiation treatments, the patient's or human research subject's
identity is verified by more than one method as the individual named in the
written directive;
(2) Each
administration is in accordance with the written directive;
(3) Therapeutic radiation machine approved
isodose plan and related calculations are in accordance with the respective
written directives by:
(a) Checking both
manual and computer generated dose calculations to verify they are correct and
in accordance with the written directive approved by the authorized user and
reviewed by the qualified medical physicist; and
(b) Verifying that any computer-generated
calculations are correctly transferred into the consoles of authorized
therapeutic medical units;
(4) Any unintended deviation from the written
directive is identified, evaluated and appropriate action is taken;
and
(5) The registrant retains a
copy of the procedures for administrations for the duration of the
registration.
(E)
Reports and Notification of Medical Events.
(1) Other than events that result from
intervention by a patient or human research subject, a registrant shall report
any event in which the administration of radiation from a radiation therapy
machine results in:
(a) A dose that differs
from the prescribed dose by more than 0.05 Sv (five rem) effective dose
equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow
dose equivalent to the skin; and either
1. The
total dose delivered differs from the prescribed dose by 20% or more;
2. The calculated weekly administered dose
differs from the weekly prescribed dose by 30% or more; or
3. For a planned treatment course of three or
fewer fractions and the calculated total administered dose differs from the
total prescribed dose by more than 10% of the total prescribed dose;
or
4. The fractionated dose
delivered differs from the prescribed dose, for a single fraction, by 50% or
more.
(b) A dose that
exceeds 0.05 Sv (five rem) effective dose equivalent, 0.5 Sv (50 rem) to an
organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from
any of the following:
1. An administration of
a dose or dosage to the wrong individual or human research subject;
or
2. An administration of a dose
delivered by the wrong mode of treatment;
(c) A dose to the skin or an organ or tissue
other than the treatment site that exceeds by 0.5 Sv (50 rem) to an organ or
tissue and 50% of the dose expected from the administration defined in the
written directive.
(2) A
registrant shall report any event resulting from intervention of a patient or
human research subject in which the administration of external beam radiation
results, or will result in, unintended permanent functional damage to an organ
or a physiological system as determined by a physician.
(3) The registrant shall notify the Agency by
telephone no later than the next calendar day after discovery of the medical
event.
(4) The registrant shall
submit a written report to the Agency within 15 days after discovery of the
medical event.
(a) The written report must
include:
1. The registrant's name;
2. The name of the prescribing
physician;
3. A brief description
of the event;
4. Why the event
occurred;
5. The effect, if any, on
the individual(s) who received the administration;
6. Actions, if any, that have been taken, or
are planned, to prevent recurrence;
7. Certification that the registrant notified
the individual (or the individual's responsible relative or guardian), and if
not, why not.
(b) The
report may not contain the individual's name or any other information that
could lead to identification of the individual.
(5) The registrant shall provide notification
of the medical event to the referring physician and also notify the individual
who is the subject of the medical event no later than 24 hours after its
discovery, unless the referring physician personally informs the registrant
either that he or she 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
medical event because of any delay in notification. To meet the requirements of
this paragraph, the notification of the individual who is the subject of the
medical event 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.
(6) Aside from the notification requirement,
nothing in 105 CMR 120.435 affects any rights or duties of registrants and
physicians in relation to each other, to individuals affected by the medical
event or to that individual's responsible relatives or guardians.
(7) A licensee shall retain a record of a
medical event in accordance with 105 CMR 120.435(E). A copy of the record
required under 105 CMR 120.435(E) shall be provided to the referring physician
if other than the registrant, within 15 days after discovery of the medical
event.
(F)
Records of Medical Events. A registrant shall retain a
record of medical events reported in accordance with 105 CMR 120.435(E) for
three years. The record must contain the licensee's name; names of the
individuals involved; the social security number or other identification number
if one has been assigned, of the individual who is the subject of the medical
event; medical event a brief description of the event; why it occurred; the
effect, if any, on the individual; the actions, if any, taken, or planned, to
prevent recurrence; and, 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.
