Section He-P 4035.14 - Notifications and Reports of Medical Events(a) 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, except permanent implant brachytherapy, 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; orc. 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 or the wrong radionuclide for a brachytherapy procedure;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; ore. A leaking sealed source;(3) A dose to the skin or an organ or tissue other than the treatment site that exceeds by: a. 0.5 Sievert (50 rem) or more of the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration; andb. Fifty percent or more of the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration.(4) For permanent implant brachytherapy, the administration of byproduct material or radiation from byproduct material (excluding sources that were implanted in the correct site but migrated outside the treatment site) that results in:a. The total source strength administered differing by 20 percent or more from the total source strength documented in the post-implantation portion of the written directive;b. The total source strength administered outside of the treatment site exceeding 20 percent of the total source strength documented in the post-implantation portion of the written directive; orc. An administration that includes the wrong radionuclide; the wrong individual or human research subject; sealed source(s) implanted directly into a location discontinuous from the treatment site, as documented in the post-implantation portion of the written directive; or a leaking sealed source resulting in a dose that exceeds 0.5 Sievert (50 rem) to an organ or tissue.(b) A licensee shall report any event resulting from intervention of a patient or human 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 licensee shall notify by telephone the DHHS/RHS no later than the next calendar day after the discovery of the medical event.(d) By an appropriate method listed in He-P 4001.08, the licensee shall submit a written report to the DHHS/RHS within 15 days after discovery of the medical event.(e) The written report required in He-P 4035.14(b) shall contain: (2) The name of the prescribing physician;(3) A brief description of the medical event, why it occurred, the effect, if any, on the individual(s) who received administration;(4) What actions, if any, have been taken or are planned to prevent recurrence;(5) Certification that the licensee notified the individual (or the individual's responsible relative or guardian) and if not, why not; and(6) The report shall not contain the individual's name or any other information that could lead to identification of the individual.(f) The licensee shall provide notification of the 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 licensee either that he or she will inform the individual or that, based on medical judgment, telling the individual would be harmful. The licensee 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 licensee shall notify the individual as soon as possible thereafter. The licensee 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 He-P 4035.14(f), 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 licensee shall inform the individual, or appropriate responsible relative or guardian that a written description of the event can be obtained from the licensee upon request. The licensee shall provide such a written description if requested.(g) Aside from the notification requirement, nothing in He-P 4035.14 affects any rights or duties of licensees and physicians in relation to each other, to individuals affected by the medical event, or the individual's responsible relatives or guardians.(h) A licensee shall annotate a copy of the report provided to the DHHS/RHS with the name of the individual who is the subject of the event and identification number or if no other identification number is available, the social security number of the individual who is the subject of the event. 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.N.H. Admin. Code § He-P 4035.14
(See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07
New. #8959, eff 8-7-07
Amended by Volume XXXV, Number 32 Filed August 13, 2015, Proposed by #10897, Effective 7/22/2015, Expires1/18/2016.Amended by Volume XXXVI Number 01, Filed January 7, 2016, Proposed by #11011, Effective 1/15/2016, Expires 1/15/2026.Amended by Volume XL Number 24, Filed June 11, 2020, Proposed by #13048, Effective 6/2/2020, Expires 6/2/2030.Amended by Volume XLII Number 45, Filed November 10, 2022, Proposed by #13473, Effective 10/25/2022, Expires 10/25/2032