ML20219A497

Nh Regulations He-P 4035.14 and 4035.38

ML20219A497
Person / Time
Issue date:	09/18/2020
From:	Michelle Beardsley Office of Nuclear Material Safety and Safeguards
To:
Beardsley M
Shared Package
ML20219A480	List: ML20219A492 ML20219A493 ML20219A494 ML20219A495 ML20219A496 ML20219A497 ML20219A498 ML20219A499 ML20232B684
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Download: ML20219A497 (4)

Text

He-P 4035.14 Records, Notifications, and Reports of Medical Events.

(a) For a medical event, the licensee shall:

(1) Notify DHHS/RHS by telephone no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after discovery of the medical event; (2) Submit a written report to DHHS/RHS within 15 days after discovery of the medical event:

a. The written report shall include:

1. The licensees name;

2. The prescribing physicians name;

3. A brief description of the event;

4. Why the event occurred;

5. The effect, if any, on the patient or human research subject;

6. What improvements are needed to prevent recurrence;

7. Actions taken to prevent recurrence;

8. Certification that the licensee notified the patient or human research subject, or the patients responsible relative or guardian, and if not, why not; and

9. If the patient or human research subject was notified, what information was provided to the patient or human research subject; and

b. Shall not include the patients or human research subjects name or other information that could lead to identification of the patient or human research subject; (3) Notify the referring physician and also notify the patients, or human research subjects responsible relative or guardian, of the medical event not later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after its discovery, unless the referring physician personally informs the licensee either that he or she will inform the patient or human research subject or that, based on medical judgment, telling the patient or human research subject would be harmful; (4) Not be required to notify the patient or human research subject without first consulting the referring physician unless the referring physician or patient or human research subject cannot be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall notify the patient or human research subject as soon as possible thereafter; (5) Not delay any appropriate medical care for the patient or human research subject, including any necessary remedial care as a result of the medical event, because of any delay in notification; and (6) Within 15 days after discovery of the medical event furnish a statement of whether the patient or human research subject was notified that a written report to the patient or human research subject by sending:

a. A copy of the report that was submitted to DHHS/RHS; or

b. A brief description of both the event and the consequences, as they may affect the patient or human research subject, provided a statement is included that the report submitted to DHHS/RHS can be obtained from the licensee.

(7) Send copy of the annotated report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event. The annotated report shall include:

a. Name of the individual who is the subject of the event; and

b. Identification number or if no other identification number is available, the social security number of the individual who is the subject of the event.

(b) Each licensee shall report any medical event to DHHS/RHS, except for an event that results from patient intervention, in which the administration of byproduct material or radiation from byproduct material results in:

(1) A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 0.05 Sievert (5 rem) effective dose equivalent, 0.5 Sievert (50 rem) to an organ or tissue, or 0.5 Sievert (50 rem) shallow dose equivalent to the skin; and

a. The total dose delivered differs from the prescribed dose by 20 percent or more;

b. The total dosage delivered differs from the prescribed dosage by 20 percent or more or falls outside the prescribed dosage range; or

c. The fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50 percent or more.

(2) A dose that exceeds 0.05 Sievert (5 rem) effective dose equivalent, 0.5 Sievert (50 rem) to an organ or tissue, or 0.5 Sievert (50 rem) shallow dose equivalent to the skin from any of the following:

a. An administration of a wrong radioactive drug containing byproduct material;

b. An administration of a radioactive drug containing byproduct material by the wrong route of administration;

c. An administration of a dose or dosage to the wrong individual or human research subject;

d. An administration of a dose or dosage delivered by the wrong mode of treatment; or

e. A leaking sealed source.

(3) A dose to the skin or an organ or tissue other than the treatment site that exceeds by 0.5 Sievert (50 rem) to the skin or an organ or tissue and 50 percent or more of the dose expected from the administration defined in the written directive (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site); or (4) An event resulting from intervention of a patient or human research subject in which the administration of byproduct material or radiation from byproduct material results or will result in unintended permanent functional damage to an organ or a physiological system, as determined by a physician.

(c) The record required in He-P 4035.14(b) shall contain:

(1) The names of all individuals involved; (2) Identification number or if no other identification number is available, the social security number of the individual who is the subject of the event; (3) A brief description of the medical event, why it occurred, the effect on the patient or human research subject; (4) What improvements are needed to prevent recurrence; and (5) The actions taken to prevent recurrence.

(d) Aside from the notification requirement, nothing in He-P 4035.14(a) through (c) shall affect any rights or duties of licensees and physicians in relation to each other, patients, or human research subjects, or the patients or the human research subjects responsible relatives or guardians.

(e) Each licensee shall retain a record of each medical event for 5 years.

He-P 4035.38 Report and Notification of a Dose to an Embryo/Fetus or a Nursing Child.

(a) A licensee shall report any dose to an embryo/fetus, that is greater than 50 millisieverts (5 rem) dose equivalent that is a result of an administration of byproduct material or radiation from byproduct material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user.

(b) A license shall report any dose to a nursing child that is a result of an administration of byproduct material to a breast-feeding individual that:

(1) Is greater than 50 millisieverts (5 rem) total effective dose equivalent; or (2) Has resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician.

(c) The licensee shall notify by telephone DHHS/RHS no later than the next calendar day after discovery of a dose to the embryo/fetus or nursing child that requires a report in He-P 4035.38(a) or He-P 4035.38(b).

(d) The licensee shall submit a written report to DHHS/RHS within 15 days after discovery of a dose to the embryo/fetus or nursing child that requires a report in He-P 4035.38(a) or He-P 4035.38(b).

The written report shall include:

(1) The licensees 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 embryo/fetus or the nursing child; (6) What actions, if any, have been taken or are planned to prevent recurrence;

(7) Certification that the licensee notified the pregnant individual or mother (or the mothers childs responsible relative or guardian), and if not, why not; and (8) The report shall not contain the individuals or childs name or any other information that could lead to identification of the individual or child.

(e) The licensee shall provide notification of the event to the referring physician and also notify the pregnant individual or mother, both hereafter referred to as the mother, no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after discovery of an event that would require reporting under He-P 4035.38(a) or He-P 4035.38(b), unless the referring physician personally informs the licensee either that he or she will inform the mother or that, based on medical judgment, telling the mother would be harmful. The licensee shall:

(1) Not be required to notify the mother without first consulting with the referring physician.

If the referring physician or mother cannot be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall make the appropriate notifications as soon as possible thereafter; (2) Not delay any appropriate medical care for the embryo/fetus or for the nursing child, including any necessary remedial care as a result of the event, because of any delay in notification; (3) Notify the mothers or childs responsible relative or guardian instead of the mother; (4) Inform the mother, or the mothers or childs responsible relative or guardian, if a verbal notification is made, that a written description of the event can be obtained from the licensee upon request; and (5) Provide such a written description if requested.

(f) In the report, a licensee shall:

(1) Annotate a copy of the report provided to DHHS/RHS with the following:

a. Name of the pregnant individual or the nursing child who is the subject of the event; and

b. Identification number or if no other identification number is available, the social security number of the individual who is the subject of the event; and (2) Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event.