New York Codes, Rules and Regulations
Title 10 - DEPARTMENT OF HEALTH
Chapter I - State Sanitary Code
Part 16 - Ionizing Radiation
General Provisions
Section 16.25 - Misadministrations
Universal Citation: 10 NY Comp Codes Rules and Regs ยง 16.25
Current through Register Vol. 46, No. 12, March 20, 2024
(a) A medical misadministration shall be the administration of:
(1) a radiopharmaceutical or radiation from a
source other than the one ordered;
(2) a radiopharmaceutical or radiation to the
wrong person;
(3) a
radiopharmaceutical or radiation by a route of administration or to a part of
the body other than that intended by the ordering physician;
(4) an activity of a radiopharmaceutical for
diagnostic purposes that differs from the activity ordered by more than 50
percent;
(5) an activity of a
radiopharmaceutical for therapeutic purposes that differs from the activity
ordered by more than 10 percent;
(6) a therapeutic radiation dose from any
source other than a radiopharmaceutical or brachytherapy source such that
errors in computation, calibration, time of exposure, treatment geometry or
equipment malfunction result in a calculated total treatment dose differing
from the final total treatment dose ordered by more than 10 percent;
(7) a therapeutic radiation dose from a
brachytherapy source such that errors in computation, calibration, treatment
time, source activity, source placement or equipment malfunction result in a
calculated total treatment dose differing from the final total treatment dose
ordered by more than 10 percent; or
(8) a therapeutic radiation dose in any
fraction of a fractionated treatment such that the administered dose in the
individual treatment or fraction differs from the dose ordered for that
individual treatment or fraction by more than 50 percent except when the
administered dose is lower than the dose ordered by more than 50 percent due to
machine interruption, or due to patient inability or decision to not finish the
treatment.
(9) A CT scan in which
any of the following occur:
(a) A CT scan is
performed on the wrong person;
(b)
A CT scan is performed on the wrong body part.
(10) a CT scan that results in damage to an
organ, organ system or results in hair loss or erythema as determined by a
physician.
(b) Records and reports of misadministrations.
(1)
Diagnostic misadministrations.
(i) Records of
misadministration as defined in subdivision (a) of this section which involve
diagnostic procedures, and the corrective actions taken pursuant to section
16.23(a)(1)(ix)
of this Part shall be retained for three years; and
(ii) if such a misadministration results in a
dose to the patient exceeding five rem to the whole body or 50 rem to any
individual organ, or the administration of iodine-131 or iodine-125 in the form
of iodide, and in a quantity greater than 30 microcuries, the licensee or
registrant shall notify the department in writing within 15 days and make and
retain a record pursuant to paragraph (3) of this subdivision.
(2) Therapy misadministrations.
(i) When a misadministration described in
paragraph (a)(5), (6) or (7) of this section, in which the percentage of error
is equal to or less than 20 percent is discovered the licensee or registrant
shall immediately investigate the cause and take corrective action; and
(a) The licensee shall make and retain a
record of all therapy misadministrations described in this subparagraph. The
record shall contain all the information called for in paragraph (3) of this
subdivision and shall be retained for six years.
(ii) When a therapy misadministration
described in paragraph (a)(1), (2), (3) or (8) of this section is discovered;
or when a misadministration described in paragraph (a)(5), (6) or (7) of this
section in which the percentage of error is greater than 20 percent is
discovered; the licensee or registrant shall notify the department by
telephone. The licensee or registrant shall also notify the referring physician
of the affected patient and the patient, of any therapy misadministration
described in this subparagraph, with the exception of misadministrations
described in paragraph (a)(1) and (8) of this section. When it is not medically
advisable to give such information to the patient the information shall be made
available to the patient's responsible relative or guardian on the patient's
behalf. These notifications must be made within 24 hours after the
misadministration is discovered. If the referring physician, patient, or the
patient's responsible relative or guardian cannot be reached within 24 hours,
the licensee or registrant shall notify them as soon as practicable. It is not
required that the patient be notified without first consulting the referring
physician; however, medical care for the patient shall not be delayed because
of this.
(iii) Within seven days
after an initial therapy misadministration report, the licensee or registrant
shall send a written report to the department. The written report must contain
the name of the licensee or registrant; the information called for in paragraph
(3) of this subdivision; and whether the licensee or registrant notified the
patient or the patient's responsible relative or guardian. A separate report is
not required when an incident report containing all the aforesaid information
is submitted to the department pursuant to Part 405 of this Title.
(3) Each licensee or registrant
shall maintain a record of each reportable misadministration for six years. The
record must contain the names of all individuals involved in the event
(including the treating 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, the effect on the patient, and actions taken to prevent
recurrence.
(4) Within seven days
after an initial therapy misadministration report made pursuant to subparagraph
(2)(ii) of this subdivision, the licensee or registrant shall provide the
patient a written report with a copy to the patient's referring physician. The
report shall contain a brief description of the event, the effect on the
patient including any change in the patient's health status which resulted or
could result from the misadministration, and recommendations for the
appropriate course of treatment or follow-up. If it is not medically advisable
to give such information to the patient, the report shall be made available to
the patient's responsible relative or guardian on the patient's behalf and
documented in the patient's treatment record.
(5) A misadministration described in 16.25
(a) (9) or (10) shall be reported to the Department in writing within 15 days
of occurrence.
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